TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02981953
• Collaborator: (none)
• Enrollment: 40
• Locations: 8
• Arm: 1
• Duration (Months): 37.4
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The current management of tricuspid regurgitation (TR) is either conservative (by medication) or by surgery, usually in concomitant with other valves repair or replacement. TR can worsen or appear late after successful mitral valve surgery which portends a poor prognosis. However, standard surgical approaches requiring cardiopulmonary bypass and especially second surgery have an excessive risks. Thus many patients are denied surgery because of unfavorable risk-benefit balance. Therefore there is a need for novel devices enabling interventional cardiologists and cardiothoracic surgeons to perform tricuspid annuloplasty by transcatheter methods. Cardioband replicates established surgical techniques (e.g., annuloplasty) using transfemoral approach, without sutures and with adjusted on the beating heart. Similar to the approved indication for mitral annuloplasty. The Cardioband System is expected to allow for treatment of patients that would otherwise not undergo Tricuspid valve repair due to the invasiveness of current techniques.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Insufficiency; Tricuspid Regurgitation; Tricuspid Valve Regurgitation; Cardiovascular Diseases; Heart Valve Diseases; Heart Diseases; Cardiac Valve Annuloplasty	Device: Cardioband Tricuspid	N/A

Detailed Description

The Cardioband Transcatheter System (Cardioband) is a marketed system that was approved for treatment of secondary (functional) mitral regurgitation (FMR) (CE granted on September 2015). The Cardioband is an annuloplasty band that is similar to a surgical annuloplasty, however deployed on the beating heart through a transvenous approach. The CE mark study with 30 subjects has been completed and documented significant reduction of severity of MR and improvement in quality of life by Minnesota living with heart failure questionnaire (MLHFQ), New York Heart Association (NYHA) and 6- minute walk test (6MWT), in subjects with moderate to severe MR. The aim of the current study is to evaluate the Cardioband annuloplasty system for repair the Tricuspid Regurgitation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System
• Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Nov 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Cardioband Tricuspid procedure Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance	Device: Cardioband Tricuspid; The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.

Outcome Measures

Primary Outcome Measures

1. Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE) [30 days]

   Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)

2. Access, Deployment and Positioning of the Cardioband Device [Intra-procedure]

   Successful access, deployment and positioning of the Cardioband device

Secondary Outcome Measures

1. Technical Success [1, 6, 12, and 24 months]

   Successful access, deployment and positioning of the Cardioband device and septolateral reduction.

2. Tricuspid Regurgitation [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

   Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.

3. Tricuspid Regurgitation [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

   All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.

4. Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

   Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab

5. Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

   All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

6. Regurgitant Volume [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

   Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

7. Regurgitant Volume [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

   All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

8. TAPSE [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

   Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.

9. TAPSE [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

   All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.

10. NYHA [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

    NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.

11. NYHA [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.

12. 6MWT [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

    Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.

13. 6MWT [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.

14. Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.

15. Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.

16. Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up] [1, 6, 12, and 24 months over baseline]

    Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.

17. Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.

18. Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.

19. Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.

20. NT-pro BNP [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.

21. Diuretic Therapy [1, 6, 12, and 24 months over baseline]

    Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.

22. Bilirubin [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.

23. Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.

24. Activity by Wearable Device [1, 6, 12, and 24 months over baseline]

    Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.

25. Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.

26. Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set] [1, 6, 12, and 24 months over baseline]

    All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Chronic functional tricuspid regurgitation (FTR) with annular diameter ≥ 40 mm with valve Systolic pulmonary pressure (sPAP) ≤ 60mmHg

2. ≥18 years old

3. New York Heart Association (NYHA) Class II-IVa

4. Symptomatic despite Guideline Directed Medical Therapy (GDMT); at minimum patient on diuretic regimen

5. LVEF ≥ 30%

6. Patient is willing and able to comply with all specified study evaluations

7. The Local Site Heart Team concur that surgery will not be offered as a treatment option

8. Transfemoral access of the Cardioband is determined to be feasible

Exclusion Criteria:

1. Aortic, mitral and/or pulmonic valve stenosis and/or regurgitation ≥ moderate

2. Severe uncontrolled hypertension (Systolic BP ≥ 180 mmHg and/or Diastolic BP ≥ 110 mm Hg)

3. Previous tricuspid valve repair or replacement

4. Trans-tricuspid pacemaker or defibrillator leads suggesting impingement of the of the tricuspid valve leaflets, as evaluated by echocardiography

5. Active endocarditis

6. MI or known unstable angina within the 30 days prior to the index procedure

7. Any percutaneous coronary intervention (PCI) or transcatheter valvular intervention within 30 days prior to the index

8. Hemodynamic instability or on IV inotropes

9. Cerebrovascular Accident (CVA) within the past 6 months

10. Subject is on chronic dialysis

11. Anemia (Hb < 9 g/dL) not corrected by transfusion

12. Bleeding disorders or hypercoaguable state

13. Active peptic ulcer or active gastrointestinal (GI) bleeding

14. Contraindication to anticoagulants

15. Known allergy to stainless steel, nickel, and/or polyester

16. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test 24 hours before any study-related radiation exposure

17. In the judgment of the Investigator, co-morbid condition(s) that could limit the subject's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

18. Life expectancy of less than 12 months

19. Impaired judgment and/or is undergoing emergency treatment

20. Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

21. intra-cardiac masses, thrombi or vegetations

22. Patients with cardiac cachexia

23. Subjects in whom transesophageal echocardiography is contraindicated

24. . Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

25. Untreated clinically significant CAD requiring revascularization

26. Echocardiographic evidence of severe right ventricular dysfunction

27. Any coronary or endovascular surgery, within 3 months prior to procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Bichat-Claude Bernard	Paris		France	18 75877
2	Bonn University - Universitätsklinikum Bonn	Bonn		Germany
3	Asklepios Klinik, St. Georg	Hamburg		Germany	5 20099
4	Universitätsklinik Hamburg Eppendorf, Herzzentrum	Hamburg		Germany
5	Universitätsklinikum Köln	Köln		Germany
6	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz		Germany
7	LMU Klinikum der Universität München, Medizinische Klinik I	Munich		Germany
8	Ospedale San Raffaele	Milano		Italy	20132

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Georg Nickenig, MD, University Hospital, Bonn

Study Documents (Full-Text)

• Study Protocol - May 25, 2017
• Statistical Analysis Plan - Oct 11, 2017

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02981953
• Other Study ID Numbers: TR1-1
• First Posted: Dec 5, 2016
• Last Update Posted: Jun 28, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Edwards Lifesciences: Valtech Cardio; Cardioband; Tricuspid
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Period Title: Overall Study
STARTED	40
COMPLETED	29
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.6 (6.6)
Sex: Female, Male (Count of Participants)
Female	29 72.5%
Male	11 27.5%
Race and Ethnicity Not Collected (Count of Participants)
Calculated BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.0 (3.9)
STS Score (Percentage of expected mortality) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage of expected mortality]	2.8 (1.5)
EUROSCORE II (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	4.4 (2.9)
NYHA Class (Count of Participants)
II	6 15%
III	32 80%
IV	2 5%
NYHA Class Grouped (Count of Participants)
I/II	6 15%
III/IV	34 85%
Left Ventricle Ejection Franction (LVEF) % (Percent Fraction) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percent Fraction]	56.9 (10.2)
FTR Etiology (Count of Participants)
Ischemic	7 17.5%
Non-ischemic	33 82.5%
Valve Surgery (Count of Participants)
Mitral Valve	4 10%
Aortic Valve	1 2.5%
Mitral and Aortic Valve	1 2.5%
Other	0 0%
Percutaneous Transcatheter Valve Replace/Repair other than Tricuspid (Count of Participants)
Transcatheter Aortic Valve Implantation	0 0%
Mitraclip	4 10%
Other	0 0%
CABG (Count of Participants)
Single	3 7.5%
Double	3 7.5%
Triple/Quadruple/Quintuple	2 5%
Percutaneous Coronary Intervention (Count of Participants)
Count of Participants [Participants]	8 20%
Any Cardiac Device without Electrodes (Count of Participants)
Parachute Implant	0 0%
LAA Closure	2 5%
PFO Closure	1 2.5%
Any Cardiac Device with Electrodes (Count of Participants)
Single Chamber Pacemaker Implant	1 2.5%
Dual Chamber Pacemaker Implant	3 7.5%
CRT Implant	0 0%
ICD Implant	2 5%
CRT-D Implant	1 2.5%
Coronary Artery Disease (Count of Participants)
Count of Participants [Participants]	17 42.5%
Previous MI (Count of Participants)
Count of Participants [Participants]	2 5%
Angina Pectoris (Count of Participants)
Count of Participants [Participants]	0 0%
Congestive Heart Failure (Count of Participants)
Count of Participants [Participants]	25 62.5%
Aortic Valve (Count of Participants)
Moderate Regurgitation	0 0%
Severe Regurgitation	0 0%
Moderate Stenosis	0 0%
Severe Stenosis	0 0%
None	40 100%
Mitral Valve (Count of Participants)
Moderate Regurgitation	0 0%
Severe Regurgitation	0 0%
Moderate Stenosis	0 0%
Severe Stenosis	0 0%
None	40 100%
Pulmonic Valve (Count of Participants)
Moderate Regurgitation	0 0%
Severe Regurgitation	0 0%
Moderate Stenosis	0 0%
Severe Stenosis	0 0%
None	40 100%
Atrial Flutter/Fibrillation (Count of Participants)
None	3 7.5%
Paroxysmal	5 12.5%
Persistant	20 50%
Chronic	12 30%
Flutter/Fibrillation Ablation (Count of Participants)
Count of Participants [Participants]	8 20%
Ventricular Tachyarrhthmia (Count of Participants)
None	38 95%
Sustained	1 2.5%
Non-sustained	0 0%
VF	1 2.5%
Diabetes (Count of Participants)
Count of Participants [Participants]	10 25%
Dyslipidemia (Count of Participants)
Count of Participants [Participants]	22 55%
Systemic Hypertension (Count of Participants)
Count of Participants [Participants]	33 82.5%
Peripheral Vascular Disease (Count of Participants)
Count of Participants [Participants]	7 17.5%
Peripheral Vascular Intervention (Count of Participants)
Count of Participants [Participants]	0 0%
Chronic Lung Disease (Moderate to Severe) (Count of Participants)
Count of Participants [Participants]	11 27.5%
Chronic Renal Disease (Count of Participants)
Count of Participants [Participants]	22 55%
Chronic Liver Disease (Count of Participants)
None/Mild	40 100%
Moderate	0 0%
Severe	0 0%
Chronic Anemia (Count of Participants)
Count of Participants [Participants]	5 12.5%
Estimated Glomerular Filtration (eGFR) (mL/min/1.73m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL/min/1.73m^2]	46.3 (17.6)
History of Endocarditis (Count of Participants)
Count of Participants [Participants]	1 2.5%
Thyreosis (Count of Participants)
Hyperthyreosis	0 0%
Hypothyreosis	12 30%
Ongoing Inotropic Support (Count of Participants)
Count of Participants [Participants]	0 0%
Elevated Pulmonary Pressure (> 35mmHG) (Count of Participants)
Count of Participants [Participants]	19 47.5%
Pulmonary Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	36.5 (11.5)
Frailty Score (Count of Participants)
Very Fit (1)	0 0%
Well (2)/Well with Treated Comorbid Disease (3)	14 35%
Apparently Vulnerable (4)	6 15%
Mildly Frail (5)/Moderately Frail (6)	20 50%
Severely Frail (7)	0 0%
Prior Stroke (Count of Participants)
Count of Participants [Participants]	4 10%
Prior Transient Ischemic Attack (Count of Participants)
Count of Participants [Participants]	2 5%
Carotid Surgery (Count of Participants)
Count of Participants [Participants]	1 2.5%
Carotid Intervention (Count of Participants)
Count of Participants [Participants]	0 0%
History of Smoking (Count of Participants)
None	26 65%
Current	3 7.5%
Past	11 27.5%
Active Malignancy (Count of Participants)
Count of Participants [Participants]	0 0%
Other Relevant Medical Conditions (Count of Participants)
Count of Participants [Participants]	32 80%

Outcome Measures

1. Primary Outcome

Title	Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)
Description	Overall rate of Major Serious Adverse Events (MSAEs)* and serious adverse device effects (SADE)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
MSAE	3 7.5%
SADE	1 2.5%

2. Primary Outcome

Title	Access, Deployment and Positioning of the Cardioband Device
Description	Successful access, deployment and positioning of the Cardioband device
Time Frame	Intra-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Count of Participants [Participants]	39 97.5%

3. Secondary Outcome

Title	Technical Success
Description	Successful access, deployment and positioning of the Cardioband device and septolateral reduction.
Time Frame	1, 6, 12, and 24 months

Outcome Measure Data

Analysis Population Description

Data was not collected

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	0

4. Secondary Outcome

Title	Tricuspid Regurgitation [Paired Baseline and Follow-Up]
Description	Data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, and Severe. Data analysis per core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline, 1 month, 30 days, 6 months, 12 months, and 24 months is 37, 33, 37, and 20 respectively. The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	37
None	0 0%
Mild	0 0%
Moderate	0 0%
Severe	37 92.5%
None	0 0%
Mild	5 12.5%
Moderate	11 27.5%
Severe	21 52.5%
None	0 0%
Mild	0 0%
Moderate	0 0%
Severe	33 82.5%
None	0 0%
Mild	3 7.5%
Moderate	10 25%
Severe	20 50%
None	0 0%
Mild	0 0%
Moderate	0 0%
Severe	27 67.5%
None	0 0%
Mild	2 5%
Moderate	9 22.5%
Severe	16 40%
None	0 0%
Mild	0 0%
Moderate	0 0%
Severe	20 50%
None	0 0%
Mild	8 20%
Moderate	7 17.5%
Severe	5 12.5%

5. Secondary Outcome

Title	Tricuspid Regurgitation [Full Analysis Data Set]
Description	All data available at each time point was reported as number of patients with TR grades between Trace, Mild, Moderate, Severe. Data analysis per core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
None	0 0%
Mild	0 0%
Moderate	0 0%
Severe	40 100%
None	0 0%
Mild	5 12.5%
Moderate	11 27.5%
Severe	21 52.5%
None	0 0%
Mild	3 7.5%
Moderate	10 25%
Severe	20 50%
None	0 0%
Mild	2 5%
Moderate	9 22.5%
Severe	16 40%
None	0 0%
Mild	8 20%
Moderate	7 17.5%
Severe	5 12.5%

6. Secondary Outcome

Title	Effective Regurgitant Orifice Area (EROA) [Paired Baseline and Follow-Up]
Description	Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 28, 21, 18, and 12 respectively. The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	38
Baseline (1 Month)	0.8 (0.5)
1 Month	0.6 (0.6)
Baseline (6 Months)	0.8 (0.5)
6 Months	0.4 (0.3)
Baseline (12 Months)	0.8 (0.5)
12 Months	0.4 (0.2)
Baseline (24 Months)	0.3 (0.2)
24 Months	-0.6 (0.4)

7. Secondary Outcome

Title	Effective Regurgitant Orifice Area (EROA) [Full Analysis Data Set]
Description	All data available for Effective regurgitant orifice area (EROA) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	0.8 (0.5)
1 Month	0.6 (0.6)
6 Months	0.4 (0.3)
12 Months	0.4 (0.2)
24 Months	0.3 (0.2)

8. Secondary Outcome

Title	Regurgitant Volume [Paired Baseline and Follow-Up]
Description	Regurgitant Volume (by Echocardiography) data available at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 11, 12, 3, and 4 respectively.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	38
Baseline (1 Month)	97.1 (35.6)
1 Month	70.7 (50.5)
Baseline (6 Months)	104.2 (33.5)
6 Months	76.9 (51.5)
Baseline (12 Months)	76.5 (32.2)
12 Months	51.2 (16.9)
Baseline (24 Months)	98.1 (41.5)
24 Months	47.2 (35.3)

9. Secondary Outcome

Title	Regurgitant Volume [Full Analysis Data Set]
Description	All data for Regurgitant Volume (by Echocardiography) at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	104.4 (37.0)
1 Month	86.7 (51.7)
6 Months	78.4 (43.2)
12 Months	79.4 (35.4)
24 Months	56.7 (37.3)

10. Secondary Outcome

Title	TAPSE [Paired Baseline and Follow-Up]
Description	Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline, 1 month, 6 months, 12 months, and 24 months is 28, 26, 24, and 17 respectively.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	38
Baseline (30 Days)	1.4 (0.4)
30 Days	1.3 (0.4)
Baseline (6 Months)	1.4 (0.4)
6 Months	1.4 (0.3)
Baseline (12 Months)	1.4 (0.3)
12 Months	1.3 (0.3)
Baseline (24 Months)	1.4 (0.4)
24 Months	1.3 (0.4)

11. Secondary Outcome

Title	TAPSE [Full Analysis Data Set]
Description	All data for Tricuspid Annular Plane Systolic Excursion at 1 month, 6 months, 12 months, and 24 months over baseline. Data analyses based on core lab assessment.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	1.5 (0.3)
30 Days	1.4 (0.4)
6 Months	1.4 (0.4)
12 Months	1.3 (0.3)
24 Months	1.4 (0.4)

12. Secondary Outcome

Title	NYHA [Paired Baseline and Follow-Up]
Description	NYHA classification data available at 1 month, 6 months, 12 months, 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline, 1 month, 6 months, 12 months, and 24 months is 37, 35, 30, and 25 respectively.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	37
I	0 0%
II	6 15%
III	30 75%
IV	1 2.5%
I	5 12.5%
II	22 55%
III	10 25%
IV	0 0%
I	0 0%
II	6 15%
III	28 70%
IV	1 2.5%
I	8 20%
II	19 47.5%
III	8 20%
IV	0 0%
I	0 0%
II	6 15%
III	23 57.5%
IV	1 2.5%
I	10 25%
II	12 30%
III	7 17.5%
IV	1 2.5%
I	0 0%
II	5 12.5%
III	20 50%
IV	0 0%
I	6 15%
II	12 30%
III	7 17.5%
IV	0 0%

13. Secondary Outcome

Title	NYHA [Full Analysis Data Set]
Description	All data available for NYHA classification at 1 month, 6 months, 12 months, and 24 months over baseline. Measure Description: NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
I	0 0%
II	6 15%
III	32 80%
IV	2 5%
I	5 12.5%
II	22 55%
III	10 25%
IV	0 0%
I	8 20%
II	19 47.5%
III	8 20%
IV	0 0%
I	10 25%
II	12 30%
III	7 17.5%
IV	1 2.5%
I	6 15%
II	12 30%
III	7 17.5%
IV	0 0%

14. Secondary Outcome

Title	6MWT [Paired Baseline and Follow-Up]
Description	Distance in meters walked during 6 Minute Walk Test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 29, 28, 25, and 17 respectively.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	29
Baseline (1 Month)	232.0 (117.5)
1 Month	289.4 (118.7)
Baseline (6 Months)	236.1 (107.8)
6 Months	280.6 (132.8)
Baseline (12 Months)	222.2 (104.7)
12 Months	273.6 (133.4)
Baseline (24 Months)	211.6 (124.9)
24 Months	294.3 (121.0)

15. Secondary Outcome

Title	6MWT [Full Analysis Data Set]
Description	Distance in meters walked during 6 minute walk test (6MWT) at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	36
Baseline	221.9 (113.0)
1 Month	289.4 (118.7)
6 Months	279.2 (130.6)
12 Months	273.6 (133.4)
24 Months	288.2 (120.2)

16. Secondary Outcome

Title	Kansas City Cardiomyopathy (KCCQ) [Paired Baseline and Follow-Up]
Description	The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 37, 35, 31, and 28 respectively.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	37
Baseline (1 Month)	44.4 (21.8)
1 Month	56.7 (24.0)
Baseline (6 Months)	44.6 (21.1)
6 Months	63.6 (23.8)
Baseline (12 Months)	43.3 (21.6)
12 Months	59.6 (22.7)
Baseline (24 Months)	47.0 (20.9)
24 Months	58.0 (24.3)

17. Secondary Outcome

Title	Kansas City Cardiomyopathy (KCCQ) [Full Analysis Data Set]
Description	The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a self-administered, 12-item questionnaire that quantifies physical limitations, symptoms, self-sufficiency, social interaction and quality of life. Scores range from 0-100, in which higher scores reflect better health status. An increase in the KCCQ-12 score reflects an improvement in symptoms for the subject. A mean difference over time of 5 points on the KCCQ-12 summary score reflects a clinically significant change in heart failure status.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	43.8 (21.9)
1 Month	56.7 (24.0)
6 Months	63.6 (23.8)
12 Months	59.6 (22.7)
24 Months	58.0 (24.3)

18. Secondary Outcome

Title	Left Ventricle Ejection Fraction (LVEF) [Paired Baseline and Follow-Up]
Description	Left ventricle ejection fraction data available for 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis based on core lab assessment.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and 1 month, 6 months, 12 months, and 24 months is 31, 30, 25, and 19 respectively.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	38
Baseline (1 Month)	56.7 (10.0)
1 Month	57.0 (8.4)
Baseline (6 Months)	56.2 (10.0)
6 Months	57.4 (7.1)
Baseline (12 Months)	56.6 (10.1)
12 Months	58.8 (6.5)
Baseline (24 Months)	57.8 (8.8)
24 Months	56.6 (6.6)

19. Secondary Outcome

Title	Left Ventricle Ejection Fraction (LVEF) [Full Analysis Data Set]
Description	All available data for left ventricle ejection fraction at 1 month, 6 months, 12 months, and 24 months over baseline. Data analysis per echo core lab.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	56.9 (10.2)
1 Month	57.0 (8.3)
6 Months	57.8 (7.1)
12 Months	59.0 (6.3)
24 Months	56.9 (6.5)

20. Secondary Outcome

Title	Left Ventricle End Diastolic Volume Index (LVEDVI) [Full Analysis Data Set]
Description	Left ventricle end diastolic volume index data available for 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	0

21. Secondary Outcome

Title	Left Ventricle End Systolic Volume Index (LVESVI) [Full Analysis Data Set]
Description	Left ventricle end systolic volume index data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	0

22. Secondary Outcome

Title	NT-pro BNP [Full Analysis Data Set]
Description	N-terminal prohormone of brain natriuretic peptide data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	2899.3 (2632.5)
1 Month	2874.5 (2860.5)
6 Months	2563.1 (2510.2)
12 Months	2095.5 (2306.4)
24 Months	2119.1 (2461.3)

23. Secondary Outcome

Title	Diuretic Therapy
Description	Diuretic Therapy data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	0

24. Secondary Outcome

Title	Bilirubin [Full Analysis Data Set]
Description	Bilirubin data available at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Bilirubin Baseline	15.7 (17.5)
Bilirubin 1 Month	14.0 (13.4)
Bilirubin 6 Months	13.0 (5.8)
Bilirubin 12 Months	11.6 (7.9)
Bilirubin 24 Months	7.4 (6.0)

25. Secondary Outcome

Title	Blood Urea Nitrogen (BUN), Serum Creatinine [Full Analysis Data Set]
Description	All available data for Blood urea nitrogen (BUN) and Serum Creatinine at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	52.8 (30.3)
1 Month	52.1 (36.0)
6 Months	64.2 (55.1)
12 Months	49.5 (34.5)
24 Months	50.5 (55.7)

26. Secondary Outcome

Title	Activity by Wearable Device
Description	Activity by wearable device available data at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

Data was not collected.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	0

27. Secondary Outcome

Title	Glutamic Oxaloacetic Transaminase (GOT) Aspartate Transaminase (AST) [Full Analysis Data Set]
Description	All data available for Glutamic oxaloacetic transaminase (GOT) and Aspartate Transaminase (AST) at 1 month, 6 months, 12 months, and 24 months over baseline.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	28.3 (9.5)
1 Month	31.9 (18.3)
6 Months	30.9 (21.3)
12 Months	32.3 (10.9)
24 Months	27.6 (9.6)

28. Secondary Outcome

Title	Glutamic Pyruvic Transaminase (GPT) Alanine Transaminase (ALT) [Full Analysis Data Set]
Description	All data available for glutamic pyruvic transaminase (GPT) Alanine Transaminase (ALT) at 1 month, 6 months, 12 months, and 24 months.
Time Frame	1, 6, 12, and 24 months over baseline

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
Measure Participants	40
Baseline	21.9 (14.0)
1 Month	25.1 (23.8)
6 Months	23.4 (18.4)
12 Months	24.6 (12.2)
24 Months	18.6 (10.2)

Adverse Events

Time Frame	2 years
Arm/Group Title	Cardioband Tricuspid Procedure
Arm/Group Description	Tricuspid valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance Cardioband Tricuspid: The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
All Cause Mortality
	Cardioband Tricuspid Procedure
	Affected / at Risk (%)	# Events
Total	9/40 (22.5%)
Serious Adverse Events
	Cardioband Tricuspid Procedure
	Affected / at Risk (%)	# Events
Total	33/40 (82.5%)
Blood and lymphatic system disorders
Anaemia	1/40 (2.5%)	1
Chronic lymphocytic leukaemia	1/40 (2.5%)	1
Iron deficiency anaemia	1/40 (2.5%)	1
Thrombocytopenia	1/40 (2.5%)	1
Cardiac disorders
Cardiac Failure	13/40 (32.5%)	19
Tricuspid valve incompetence	6/40 (15%)	6
Atrioventricular block complete	3/40 (7.5%)	3
Right ventricular failure	3/40 (7.5%)	3
Atrial fibrillation	2/40 (5%)	2
Cardiac failure congestive	2/40 (5%)	2
Ventricular tachycardia	2/40 (5%)	2
Angina unstable	1/40 (2.5%)	1
Bradycardia	1/40 (2.5%)	1
Cardiac tamponade	1/40 (2.5%)	1
Cardiorenal syndrome	1/40 (2.5%)	1
Chest pain	1/40 (2.5%)	1
Chronotropic incompetence	1/40 (2.5%)	1
Coronary artery disease	1/40 (2.5%)	1
Coronary artery occlusion	1/40 (2.5%)	1
Coronary artery perforation	1/40 (2.5%)	1
Mitral valve incompetence	1/40 (2.5%)	1
Sinus node dysfunction	1/40 (2.5%)	1
Ventricular fibrillation	1/40 (2.5%)	1
Endocrine disorders
Diabetic foot infection	1/40 (2.5%)	1
Hyperglycaemia	1/40 (2.5%)	1
Eye disorders
Cataract	1/40 (2.5%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	3/40 (7.5%)	3
Constipation	1/40 (2.5%)	1
Diverticulosis	1/40 (2.5%)	1
Gastric ulcer haemorrhage	1/40 (2.5%)	1
Jejunal ulcer	1/40 (2.5%)	1
MalloryWeiss Syndrome	1/40 (2.5%)	1
Melaena	1/40 (2.5%)	1
Oesophageal rupture	1/40 (2.5%)	1
General disorders
Death	1/40 (2.5%)	1
Hernia	1/40 (2.5%)	1
Infections and infestations
Bacteraemia	1/40 (2.5%)	1
Clostridium difficile colitis	1/40 (2.5%)	1
Erysipelothrix infection	1/40 (2.5%)	1
Herpes zoster	1/40 (2.5%)	1
Lung infection	1/40 (2.5%)	1
Pneumonia	1/40 (2.5%)	1
Staphylococcal sepsis	1/40 (2.5%)	1
Upper respiratory tract infection	1/40 (2.5%)	1
Injury, poisoning and procedural complications
Animal Bite	1/40 (2.5%)	1
Fall	1/40 (2.5%)	1
Humerus fracture	1/40 (2.5%)	1
Overdose	1/40 (2.5%)	1
Thoracic vertebral fracture	1/40 (2.5%)	1
Vascular access site haemorrhage	1/40 (2.5%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/40 (2.5%)	1
Femur Fracture	1/40 (2.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer	1/40 (2.5%)	1
Nervous system disorders
Cerebrovascular accident	2/40 (5%)	2
Cerebral Haemorrhage	1/40 (2.5%)	1
Disturbance in attention	1/40 (2.5%)	1
Transient ischaemic attack	1/40 (2.5%)	1
Product Issues
Device dislocation	1/40 (2.5%)	1
Psychiatric disorders
Adjustment disorder with depressed mood	1/40 (2.5%)	1
Somatic symptom disorder	1/40 (2.5%)	1
Suicide attempt	1/40 (2.5%)	1
Renal and urinary disorders
Acute kidney injury	3/40 (7.5%)	6
Respiratory, thoracic and mediastinal disorders
Pleural effusion	4/40 (10%)	6
Cardiopulmonary failure	1/40 (2.5%)	1
Chronic obstructive pulmonary disease	1/40 (2.5%)	1
Epistaxis	1/40 (2.5%)	1
Pneumonia	1/40 (2.5%)	1
Pulmonary oedema	1/40 (2.5%)	1
Sleep apnoea syndrome	1/40 (2.5%)	1
Skin and subcutaneous tissue disorders
Dermatitis allergic	1/40 (2.5%)	1
Skin abrasion	1/40 (2.5%)	1
Vascular disorders
Haemorrhage	2/40 (5%)	2
Syncope	1/40 (2.5%)	4
Haematoma	1/40 (2.5%)	1
Peripheral arterial occlusive disease	1/40 (2.5%)	1
Peripheral artery occlusion	1/40 (2.5%)	1
Pulmonary embolism	1/40 (2.5%)	1
Stasis dermatitis	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Cardioband Tricuspid Procedure
	Affected / at Risk (%)	# Events
Total	34/40 (85%)
Blood and lymphatic system disorders
Anaemia	9/40 (22.5%)	10
Iron deficiency anaemia	3/40 (7.5%)	4
Cardiac disorders
Arteriospasm coronary	3/40 (7.5%)	3
Atrial fibrillation	5/40 (12.5%)	6
Atrioventricular block complete	3/40 (7.5%)	3
Cardiac failure	13/40 (32.5%)	20
Cardiac failure congestive	2/40 (5%)	2
Coronary artery occlusion	2/40 (5%)	2
Mitral valve incompetence	3/40 (7.5%)	3
Right ventricular failure	4/40 (10%)	5
Tricuspid valve incompetence	8/40 (20%)	8
Ventricular tachycardia	3/40 (7.5%)	4
Endocrine disorders
Hyperthyroidism	2/40 (5%)	2
Gastrointestinal disorders
Constipation	2/40 (5%)	2
Diverticulum	2/40 (5%)	2
Gastrointestinal haemorrhage	2/40 (5%)	3
Haemorrhoids	2/40 (5%)	2
Large intestine polyp	2/40 (5%)	2
Melaena	2/40 (5%)	2
Vomiting	2/40 (5%)	2
General disorders
Impaired healing	2/40 (5%)	2
Infections and infestations
Infection	3/40 (7.5%)	3
Pneumonia	7/40 (17.5%)	8
Upper respiratory tract infection	2/40 (5%)	2
Urinary tract infection	8/40 (20%)	11
Injury, poisoning and procedural complications
Fall	2/40 (5%)	5
Postoperative delirium	2/40 (5%)	2
Vascular access site haemorrhage	2/40 (5%)	2
Investigations
Blood thyroid stimulating hormone decreased	3/40 (7.5%)	3
Brain natriuretic peptide increased	2/40 (5%)	2
C-reactive protein increased	3/40 (7.5%)	3
Haemoglobin decreased	5/40 (12.5%)	5
Troponin increased	2/40 (5%)	2
Metabolism and nutrition disorders
Dehydration	2/40 (5%)	2
Hyperkalaemia	3/40 (7.5%)	3
Musculoskeletal and connective tissue disorders
Back pain	4/40 (10%)	4
Nervous system disorders
Cerebrovascular accident	2/40 (5%)	3
Product Issues
Device dislocation	4/40 (10%)	4
Device malfunction	2/40 (5%)	2
Renal and urinary disorders
Acute kidney injury	12/40 (30%)	16
Chronic Kidney disease	3/40 (7.5%)	3
Urinary retention	4/40 (10%)	4
Respiratory, thoracic and mediastinal disorders
Pleural effusion	6/40 (15%)	9
Pneumonia	4/40 (10%)	4
Skin and subcutaneous tissue disorders
Rash	3/40 (7.5%)	3
Vascular disorders
Haematoma	2/40 (5%)	3
Haemorrhage	3/40 (7.5%)	3
Hypertension	2/40 (5%)	2
Peripheral arterial occlusive disease	2/40 (5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.