Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Regurgitation
- Sponsor
- LMU Klinikum
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- MACCE
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Daniel Braun, MD
MD, Attending Physician
LMU Klinikum
Eligibility Criteria
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
Outcomes
Primary Outcomes
MACCE
Time Frame: 1-12 months
TR grade, Echo (grade 0-4)
Time Frame: 1-12 months
grade 0-4: 0: no tricuspid regurgitation, 4: massive TR
Secondary Outcomes
- 6 Minute walk distance(1-12 months)
- NT-proBNP(1-12 months)
- NYHA status(1-12 months)
- MLHFQ(1-12 months)