Aortic Valve Replacement With Trifecta(TM)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00475709
• Collaborator: (none)
• Enrollment: 1,022
• Locations: 18
• Arm: 1
• Duration (Months): 55
• Patients Per Site: 56.8
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

To confirm the clinical safety and effectiveness of the Trifecta valve.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Insufficiency; Regurgitation, Aortic Valve; Aortic Valve Incompetence; Aortic Valve Stenosis	Device: Trifecta Aortic Heart Valve	N/A

Detailed Description

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1022 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Observational, Prospective Evaluation of the Trifecta Valve
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trifecta Aortic Heart Valve All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.	Device: Trifecta Aortic Heart Valve; Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.

Outcome Measures

Primary Outcome Measures

1. Late Adverse Event Rates [Events occurring greater than or equal to 31 days post-implant.]

   Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]

2. Characterize Patient NYHA Functional Classification Status. [1 year]

   The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.

3. Characterize the Hemodynamic Performance of the Valve. [1 year]

   Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).

• Legal age.

• Signed informed consent prior to surgery.

• Willing to complete all follow-up requirements.

Exclusion Criteria:

• Pregnant or nursing women.

• Have already had a valve replaced other than the aortic valve.

• Needs another valve replaced.

• Cannot return for required follow-up visits.

• Have active endocarditis.

• Acute preoperative neurological event (such as a stroke).

• Renal dialysis.

• History of substance abuse within one year, or a prison inmate.

• Participating in another study.

• Life expectancy less than two years.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital	Los Angeles	California	United States	90033
2	Sarasota Memorial Hospital/Clinical Research Center	Sarasota	Florida	United States	34239
3	Loyola University Medical Center	Maywood	Illinois	United States	60153
4	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
5	Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
6	Mayo Clinic	Rochester	Minnesota	United States	55905
7	NYU Medical Center	New York	New York	United States	10016
8	Columbia University Medical Center	New York	New York	United States	10032
9	Mission Hospitals	Asheville	North Carolina	United States	28801
10	Duke University Medical Center	Durham	North Carolina	United States	27710
11	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
12	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104
13	Main Line Health Heart Center	Wynnewood	Pennsylvania	United States	19096
14	Vanderbilt Medical Center	Nashville	Tennessee	United States	37212
15	Cardiothoracic and Vascular Surgeons	Austin	Texas	United States	78756
16	Baylor College of Medicine	Houston	Texas	United States	77030
17	Intermountain Medical Center	Murray	Utah	United States	84157
18	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53201

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Hartzell Schaff, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00475709
• Other Study ID Numbers: CS0501
• First Posted: May 21, 2007
• Last Update Posted: Feb 19, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Abbott Medical Devices: aortic valve; heart valve; tissue valve; bioprosthesis; valve disorder; valve disease; cardiac surgery; aortic valve stenosis; aortic valve regurgitation
• Additional relevant MeSH terms: Aortic Valve Stenosis; Aortic Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Subjects Implanted With Trifecta Valve
Arm/Group Description	All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Period Title: Overall Study
STARTED	1022
Eligible of Analysis	1014
COMPLETED	946
NOT COMPLETED	76

Baseline Characteristics

Arm/Group Title	Trifecta Aortic Heart Valve
Arm/Group Description	All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Overall Participants	1014
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.5 (9.0)
Sex: Female, Male (Count of Participants)
Female	364 35.9%
Male	650 64.1%

Outcome Measures

1. Primary Outcome

Title	Late Adverse Event Rates
Description	Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
Time Frame	Events occurring greater than or equal to 31 days post-implant.

Outcome Measure Data

Analysis Population Description

Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.

Arm/Group Title	Trifecta Aortic Heart Valve
Arm/Group Description	All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Measure Participants	1014
Thromboembolism	1.90
Valve Thrombosis	0
Major Bleed	2.61
Nonstructural Dysfunction	0.12
Endocarditis	1.07
Clinically Significant Hemolysis	0.0
Structural Deterioration	0.12
Valve Reoperation	0.59
Mortality (All Cause)	2.72

2. Primary Outcome

Title	Characterize Patient NYHA Functional Classification Status.
Description	The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.

Arm/Group Title	Trifecta Aortic Heart Valve
Arm/Group Description	All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Measure Participants	1014
NYHA I at 1 year	85.3 8.4%
NYHA II at 1 year	13.5 1.3%
NYHA III at 1 year	1.2 0.1%
NYHA IV at 1 year	0 0%

3. Primary Outcome

Title	Characterize the Hemodynamic Performance of the Valve.
Description	Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Analysis based on per protocol. Eight subjects did not meet eligibility criteria and were excluded from this analysis.

Arm/Group Title	Trifecta Aortic Heart Valve
Arm/Group Description	All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Measure Participants	1014
19 mm Mean Gradient (1 year)	10.7 (4.6)
21 mm Mean Gradient (1 year)	8.1 (3.5)
23 mm Mean Gradient (1 year)	7.2 (2.8)
25 mm Mean Gradient (1 year)	6.2 (2.7)
27 mm Mean Gradient (1 year)	4.8 (2.0)
29 mm Mean Gradient (1 year)	4.7 (1.6)

Adverse Events

Adverse Event Reporting Description	Early (adverse events occuring on or before 30 days post procedure) and Late(adverse events occurring greater than or equal to 31 days post procedure) are combined for the Valve Related Serious Adverse Event data analysis.
Arm/Group Title	Subjects Implanted With Trifecta Valve
Arm/Group Description
All Cause Mortality
	Subjects Implanted With Trifecta Valve
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Subjects Implanted With Trifecta Valve
	Affected / at Risk (%)	# Events
Total	147/1014 (14.5%)
Blood and lymphatic system disorders
Clinically Significant Hemolysis	0/1014 (0%)	0
Cardiac disorders
Thromboembolism	40/1014 (3.9%)	43
Valve Thrombosis	0/1014 (0%)	0
Non-structural dysfunction	4/1014 (0.4%)	4
Structural deterioration	1/1014 (0.1%)	1
Valve related Mortality	5/1014 (0.5%)	5
General disorders
Major Bleed	96/1014 (9.5%)	103
Infections and infestations
Endocarditis	9/1014 (0.9%)	9
Surgical and medical procedures
Reoperation	6/1014 (0.6%)	6
Other (Not Including Serious) Adverse Events
	Subjects Implanted With Trifecta Valve
	Affected / at Risk (%)	# Events
Total	0/1014 (0%)

Limitations/Caveats

The SAEs reported are based on the Edmunds criteria noted in Edmunds LH, Clark RE, Cohn LH, Grunkemeier GL, Miller CM, Weisel RD. Guidelines for reporting Morbidity and Mortality after Cardiac Valvular Operations. Ann Thorac Surg 1996;62:932-5.

More Information

Certain Agreements

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