Contour3D: Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01585779
• Collaborator: (none)
• Enrollment: 64
• Locations: 3
• Duration (Months): 49
• Patients Per Site: 21.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to gather clinical information on the hemodynamic performance of the Contour 3D® and Tri-Ad® Tricuspid Annuloplasty Rings in a post-market environment.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency	Device: Contour 3D® implant for tricuspid valve repair; Device: Tri-Ad® implant for tricuspid valve repair

Detailed Description

The primary goal of the TV repair procedure is to relieve patients from TV insufficiency or reduce TV stenosis. This study will evaluate the hemodynamic efficacy of the Contour 3D® and Tri-Ad® ring and characterize the effect of the TV repair through assessment of right atrial size and right ventricular function. Additionally, this study will characterize the patient population for whom a Contour 3D® or Tri-Ad® ring is chosen to repair TV insufficiency. Health status and adverse events (AE) will be assessed.

Study Design

• Study Type: Observational
• Actual Enrollment: 64 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Contour 3D®/TriAd® Tricuspid Annuloplasty Ring Post-Market Clinical Trial
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Contour 3D® Implant The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure	Device: Contour 3D® implant for tricuspid valve repair; Tricuspid annuloplasty ring
Tri-Ad® Implant The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure	Device: Tri-Ad® implant for tricuspid valve repair; Tricuspid annuloplasty ring

Outcome Measures

Primary Outcome Measures

1. Change in the Degree of Tricuspid Regurgitation [Preimplant through Discharge]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.

2. Change in the Degree of Tricuspid Regurgitation [Preimplant through 6 Months]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.

3. Change in the Degree of Tricuspid Regurgitation [Preimplant through 12 Months]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.

4. The Mean Gradient Across the Tricuspid Valve [Discharge]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

5. The Mean Gradient Across the Tricuspid Valve [6 months]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

6. The Mean Gradient Across the Tricuspid Valve [12 months]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant

7. Change in the Degree of TV Leaflet Coaptation Length [Preimplant through Discharge]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.

8. Change in the Degree of TV Leaflet Coaptation Length [Preimplant through 6 Months]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.

9. Change in the Degree of TV Leaflet Coaptation Length [Preimplant through 12 Months]

   The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.

10. Change in the Degree of TV Leaflet Tethering Height [Preimplant through Discharge]

    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.

11. Change in the Degree of TV Leaflet Tethering Height [Preimplant through 6 Months]

    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.

12. Change in the Degree of TV Leaflet Tethering Height [Preimplant through 12 Months]

    The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant

Secondary Outcome Measures

1. Change in the Right Ventricle (RV) Diastolic Area [Preimplant through Discharge]

   The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.

2. Change in the Right Ventricle (RV) Diastolic Area [Preimplant through 6 Months]

   The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.

3. Change in the Right Ventricle (RV) Diastolic Area [Preimplant through 12 Months]

   The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant

4. Change in the Tricuspid Annular (Basal) Diameter [Preimplant through Discharge]

   The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant

5. Change in the Tricuspid Annular (Basal) Diameter [Preimplant through 6 Months]

   The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant

6. Change in the Tricuspid Annular (Basal) Diameter [Preimplant through 12 Months]

   The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant

7. Change in the RV Fractional Area [Preimplant through Discharge]

   The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.

8. Change in the RV Fractional Area [Preimplant through 6 Months]

   The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.

9. Change in the RV Fractional Area [Preimplant through 12 Months]

   The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.

10. Demographic Data [Baseline]

    Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status

11. Change in New York Heart Association (NYHA) Classification [Preimplant through Discharge]

    Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.

12. Change in New York Heart Association (NYHA) Classification [Preimplant through 6 months]

    Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.

13. Change in New York Heart Association (NYHA) Classification . [Preimplant through 12 months]

    Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject or legal guardian willing and able to sign and date the Informed Consent Form (and Authorization to Use and Disclose Health Information Form, if applicable)

• Subject indicated for a concomitant surgical repair of the TV

• Subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred

Exclusion Criteria:

• Subject with a degenerative TV condition

• Subject with primary TV regurgitation

• Subject with a previous TV repair or replacement

• Subject indicated for a stand-alone TV repair

• Subject currently participating in an investigational drug or another device study

• Subject with life expectancy of less than one year

• Subject is pregnant or desires to be pregnant within 12 months following implantation

• Subject is under 18 or over 85 years of age

• Subject with active endocarditis

• Subject with valvular retraction with severely reduced mobility

• Subject with a heavily calcified TV

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Heart & Vascular Care at Aventura	Aventura	Florida	United States	33308
2	University of Michigan	Ann Arbor	Michigan	United States	48109
3	Mission Hospital Research Institute	Asheville	North Carolina	United States	28801

Sponsors and Collaborators

• Medtronic Cardiovascular

Investigators

• Study Director: Eric Vang, Medtronic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor website

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT01585779
• Other Study ID Numbers: 10030481DOC
• First Posted: Apr 26, 2012
• Last Update Posted: May 10, 2017
• Last Verified: May 1, 2017

• Additional relevant MeSH terms: Tricuspid Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Period Title: Overall Study
STARTED	36	28
COMPLETED	26	21
NOT COMPLETED	10	7

Baseline Characteristics

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant	Total
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring	Total of all reporting groups
Overall Participants	36	28	64
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 36.1%	3 10.7%	16 25%
>=65 years	23 63.9%	25 89.3%	48 75%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.4 (11.6)	73.7 (8.5)	70.7 (10.6)
Sex: Female, Male (Count of Participants)
Female	15 41.7%	18 64.3%	33 51.6%
Male	21 58.3%	10 35.7%	31 48.4%

Outcome Measures

1. Primary Outcome

Title	Change in the Degree of Tricuspid Regurgitation
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	35	25
Improved	27 75%	18 64.3%
No Change	6 16.7%	6 21.4%
Worsened	2 5.6%	1 3.6%

2. Primary Outcome

Title	Change in the Degree of Tricuspid Regurgitation
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Time Frame	Preimplant through 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	30	20
Improved	23 63.9%	14 50%
No Change	6 16.7%	4 14.3%
Worsened	1 2.8%	2 7.1%

3. Primary Outcome

Title	Change in the Degree of Tricuspid Regurgitation
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment. Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant.
Time Frame	Preimplant through 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	25	20
Improved	17 47.2%	12 42.9%
No Change	5 13.9%	7 25%
Worsened	3 8.3%	1 3.6%

4. Primary Outcome

Title	The Mean Gradient Across the Tricuspid Valve
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Time Frame	Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	35	26
Median (Inter-Quartile Range) [mmHg]	2.2	2.0

5. Primary Outcome

Title	The Mean Gradient Across the Tricuspid Valve
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	30	20
Median (Inter-Quartile Range) [mmHg]	2.0	2.2

6. Primary Outcome

Title	The Mean Gradient Across the Tricuspid Valve
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	25	21
Median (Inter-Quartile Range) [mmHg]	2.0	2.0

7. Primary Outcome

Title	Change in the Degree of TV Leaflet Coaptation Length
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	34	24
Median (Inter-Quartile Range) [mm]	0.0	0.0

8. Primary Outcome

Title	Change in the Degree of TV Leaflet Coaptation Length
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Time Frame	Preimplant through 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	29	19
Median (Inter-Quartile Range) [mm]	1.0	0.0

9. Primary Outcome

Title	Change in the Degree of TV Leaflet Coaptation Length
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.
Time Frame	Preimplant through 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	25	20
Median (Inter-Quartile Range) [mm]	0.0	0.0

10. Primary Outcome

Title	Change in the Degree of TV Leaflet Tethering Height
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	34	24
Median (Inter-Quartile Range) [mm]	-0.8	0.5

11. Primary Outcome

Title	Change in the Degree of TV Leaflet Tethering Height
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.
Time Frame	Preimplant through 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	29	19
Median (Inter-Quartile Range) [mm]	0.6	1.0

12. Primary Outcome

Title	Change in the Degree of TV Leaflet Tethering Height
Description	The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant
Time Frame	Preimplant through 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	25	20
Median (Inter-Quartile Range) [mm]	1.0	1.0

13. Secondary Outcome

Title	Change in the Right Ventricle (RV) Diastolic Area
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	31	22
Median (Inter-Quartile Range) [mm^2]	-140.0	141.0

14. Secondary Outcome

Title	Change in the Right Ventricle (RV) Diastolic Area
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.
Time Frame	Preimplant through 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	28	17
Median (Inter-Quartile Range) [mm^2]	160.5	70.6

15. Secondary Outcome

Title	Change in the Right Ventricle (RV) Diastolic Area
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant
Time Frame	Preimplant through 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	24	18
Median (Inter-Quartile Range) [mm^2]	395.0	211.0

16. Secondary Outcome

Title	Change in the Tricuspid Annular (Basal) Diameter
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	34	23
Median (Inter-Quartile Range) [mm]	-4.0	0.0

17. Secondary Outcome

Title	Change in the Tricuspid Annular (Basal) Diameter
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant
Time Frame	Preimplant through 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	29	18
Median (Inter-Quartile Range) [mm]	3.0	1.0

18. Secondary Outcome

Title	Change in the Tricuspid Annular (Basal) Diameter
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant
Time Frame	Preimplant through 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	25	19
Median (Inter-Quartile Range) [mm]	4.0	1.0

19. Secondary Outcome

Title	Change in the RV Fractional Area
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	31	22
Median (Inter-Quartile Range) [percent]	-3.8	-1.8

20. Secondary Outcome

Title	Change in the RV Fractional Area
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.
Time Frame	Preimplant through 6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	28	17
Median (Inter-Quartile Range) [percent]	-0.8	-6.2

21. Secondary Outcome

Title	Change in the RV Fractional Area
Description	The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.
Time Frame	Preimplant through 12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	24	18
Median (Inter-Quartile Range) [percent]	-0.4	-3.6

22. Secondary Outcome

Title	Demographic Data
Description	Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	36	28
Previous Valve Repair	5 13.9%	1 3.6%
Previous Valve Replacement	2 5.6%	3 10.7%
Previous CABG	6 16.7%	5 17.9%
CAD	12 33.3%	15 53.6%
CHF	19 52.8%	13 46.4%
Atrial Fibrillation/flutter	22 61.1%	18 64.3%
MI	4 11.1%	4 14.3%
Diabetes	11 30.6%	6 21.4%
Hypertension	27 75%	24 85.7%
Moderate or severe aortic valve insufficiency	3 8.3%	3 10.7%
Moderate or severe mitral valve insufficiency	31 86.1%	23 82.1%

23. Secondary Outcome

Title	Change in New York Heart Association (NYHA) Classification
Description	Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.
Time Frame	Preimplant through Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	36	26
Improved	19 52.8%	15 53.6%
No Change	13 36.1%	6 21.4%
Worsened	4 11.1%	5 17.9%

24. Secondary Outcome

Title	Change in New York Heart Association (NYHA) Classification
Description	Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.
Time Frame	Preimplant through 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	30	21
Improved	20 55.6%	19 67.9%
No Change	8 22.2%	1 3.6%
Worsened	2 5.6%	1 3.6%

25. Secondary Outcome

Title	Change in New York Heart Association (NYHA) Classification .
Description	Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.
Time Frame	Preimplant through 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Contour 3D® Implant	Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
Measure Participants	26	21
Improved	19 52.8%	17 60.7%
No Change	7 19.4%	3 10.7%
Worsened	0 0%	1 3.6%

Adverse Events

Time Frame	Device or procedure related Adverse events (AEs) were collected from study enrollment to study closure, up to 1 year.
Adverse Event Reporting Description	All new or worsening device or procedure related AEs were collected through1 year.
Arm/Group Title	Contour 3D® Implant		Tri-Ad® Implant
Arm/Group Description	The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring		The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
All Cause Mortality
	Contour 3D® Implant		Tri-Ad® Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Contour 3D® Implant		Tri-Ad® Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/36 (44.4%)		10/28 (35.7%)
Blood and lymphatic system disorders
Coagulopathy	0/36 (0%)	0	1/28 (3.6%)	1
Thrombocytopenia	1/36 (2.8%)	1	0/28 (0%)	0
Cardiac disorders
Atrial fibrillation	2/36 (5.6%)	3	3/28 (10.7%)	3
Atrioventricular block complete	2/36 (5.6%)	2	0/28 (0%)	0
Atrioventricular block second degree	2/36 (5.6%)	2	0/28 (0%)	0
Bradycardia	1/36 (2.8%)	1	0/28 (0%)	0
Cardiac failure congestive	1/36 (2.8%)	1	1/28 (3.6%)	1
Coronary artery embolism	1/36 (2.8%)	1	0/28 (0%)	0
Nodal rhythm	1/36 (2.8%)	1	2/28 (7.1%)	2
Sinus node dysfunction	2/36 (5.6%)	2	1/28 (3.6%)	1
Gastrointestinal disorders
Ileus	1/36 (2.8%)	1	0/28 (0%)	0
Injury, poisoning and procedural complications
Postoperative respiratory failure	1/36 (2.8%)	1	0/28 (0%)	0
Investigations
Cardiac output decreased	1/36 (2.8%)	1	0/28 (0%)	0
Nervous system disorders
Cerebrovascular accident	1/36 (2.8%)	1	1/28 (3.6%)	2
Renal and urinary disorders
Renal failure	1/36 (2.8%)	1	1/28 (3.6%)	1
Renal failure acute	3/36 (8.3%)	3	0/28 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	1/36 (2.8%)	1	0/28 (0%)	0
Respiratory failure	1/36 (2.8%)	1	2/28 (7.1%)	2
Vascular disorders
Hypotension	1/36 (2.8%)	1	1/28 (3.6%)	1
Other (Not Including Serious) Adverse Events
	Contour 3D® Implant		Tri-Ad® Implant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/36 (5.6%)		0/28 (0%)
Cardiac disorders
Atrioventricular block first degree	2/36 (5.6%)	2	0/28 (0%)	0
Atrial fibrillation	2/36 (5.6%)	2	0/28 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.