NCT02981953

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tricuspid Valve Insufficiency
• Tricuspid Regurgitation
• Tricuspid Valve Regurgitation
• Cardiovascular Diseases
• Heart Valve Diseases
• Heart Diseases
• Cardiac Valve Annuloplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-01-01
• Completion: 2019-11-12
• First posted: 2016-12-05
• Last updated: 2021-06-28
• Results posted: 2021-06-28

Locations

8 sites across 3 countries: France, Germany, Italy