TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

N/ACompletedNCT02981953

Edwards Lifesciences40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Hôpital Bichat-Claude Bernard

Paris, France

Bonn University - Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinikum Köln

Cologne, Germany

Asklepios Klinik, St. Georg

Hamburg, Germany

Universitätsklinik Hamburg Eppendorf, Herzzentrum

Hamburg, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Germany

LMU Klinikum der Universität München, Medizinische Klinik I

Munich, Germany

Ospedale San Raffaele

Milan, Italy

Outcomes

Primary Outcomes

Major Serious Adverse Events (MSAEs) and Serious Adverse Device Effects (SADE)

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

Time frame: 30 days

Access, Deployment and Positioning of the Cardioband Device

Successful access, deployment and positioning of the Cardioband device

Time frame: Intra-procedure

Secondary Outcomes

Technical Success

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

Time frame: 1, 6, 12, and 24 months

Tricuspid Regurgitation [Paired Baseline and Follow-Up]

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.