Last updated on February 2018

TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System

Brief description of study

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), Ney 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.

Clinical Study Identifier: NCT02981953

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Alec Vahanian, Prof

Bichat hospital
Paris, France
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George Nickenig, Prof. Dr. MD

Bonn University
Bonn, Germany
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Karl-Heinz Kuck, Prof

Asklepios Klinik, St. Georg
Hamburg, Germany
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Joachim Schofer, Prof.

Medizinisches Versorgungszentrum, Hamburg
Hamburg, Germany
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Stephan Baldus,

Koln, Universit tsklinikum
Koln, Germany
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Ralph Stephan von Bardeleben, Dr. ...

Universitatsmedizin Mainz
Mainz, Germany
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Jörg Hausleiter,

M nchen, LMU Klinikum der Universit t M nchen
Munich, Germany
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Azeem Latib, MD

Hospital san raffaele
Milano, Italy
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