MitraClip for Severe TR — TVrepair  

Tricuspid Regurgitation Clinical Trial

Official title: Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System

Status Not yet recruiting

Clinical Trial Summary

The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, highly symptomatic patients with severe tricuspid regurgitation (TR).

Clinical Trial Description

The primary objectives of this prospective analysis were to determine the feasibility in terms of success rate and short-term clinical follow-up at 30 days. In this context procedural success was defined as reduction of at least one TR grade. At 30-days after the procedure, a clinical follow up was performed in the heart failure outpatient clinic of our department including transthoracic echocardiography for the evaluation of TR grades. Furthermore, the investigators determined NYHA functional class and the incidence of major adverse cardiac and cerebrovascular events (MACCE).

Secondary objectives were the assessment of right ventricular function, the 6-minute walk distance, NT-proBNP as well as quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at 30-days follow up. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

• NCT number: NCT02863549
• Study type: Interventional
• Source: Klinikum der Universitaet Muenchen
• Contact: Daniel Braun, MD
• Phone: +49 89 4400
• Email: Daniel.Braun@med.uni-muenchen.de
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2016
• Completion date: December 2017