MitraClip for Severe TR (TVrepair)

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

• Study Contact: Name: Daniel Braun, MD; Phone Number: 73052 +49 89 4400; Email: Daniel.Braun@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • München, Bavaria, Germany, 81377
      • Klinikum Großhadern University Hospital
      • Contact: Daniel Braun, MD; Phone Number: 73052 +49 89 4400; Email: Daniel.Braun@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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

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)	grade 0-4: 0: no tricuspid regurgitation, 4: massive TR	1-12 months
MACCE		1-12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Daniel Braun, MD, Klinikum der Universität München

Study record dates

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): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 6, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: MucS001-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No