TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

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.

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.

Eligibility Criteria:
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