NCT02863549

MitraClip for Severe TR

Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: LMU Klinikum · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	MitraClip in tricuspid valve	MitraClip in tricuspid valve

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-08-11
• Last updated: 2016-08-11

Locations

1 site across 1 country: Germany