MitraClip for Severe TR (TVrepair)

August 6, 2016 updated by: Daniel Braun, MD, LMU Klinikum

Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System

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).

Study Overview

Status

Unknown

Conditions

Tricuspid Regurgitation

Intervention / Treatment

Device: MitraClip in tricuspid valve

Detailed 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 Type

Interventional

Enrollment (Anticipated)

100

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Bavaria
  - München, Bavaria, Germany, 81377
    - Klinikum Großhadern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

right-sided heart failure due to moderate-to-severe tricuspid regurgitation
patients deemed inoperable by the heart Team

Exclusion Criteria:

poor Echo-image quality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TR grade, Echo (grade 0-4) Time Frame: 1-12 months	grade 0-4: 0: no tricuspid regurgitation, 4: massive TR	1-12 months
MACCE Time Frame: 1-12 months		1-12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
NYHA status Time Frame: 1-12 months	1-12 months
6 Minute walk distance Time Frame: 1-12 months	1-12 months
NT-proBNP Time Frame: 1-12 months	1-12 months
MLHFQ Time Frame: 1-12 months	1-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMU Klinikum

Investigators

Principal Investigator: Daniel Braun, MD, Klinikum der Universität München

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 6, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)