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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
MitraClip in tricuspid valve
Klinikum Großhadern University Hospital
München, Bavaria, Germany
TR grade, Echo (grade 0-4)
grade 0-4: 0: no tricuspid regurgitation, 4: massive TR
Time frame: 1-12 months
MACCE
Time frame: 1-12 months
NYHA status
Time frame: 1-12 months
6 Minute walk distance
Time frame: 1-12 months
NT-proBNP
Time frame: 1-12 months
MLHFQ
Time frame: 1-12 months
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