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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MitraClip in tricuspid valve | Device | MitraClip in tricuspid valve |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA status | 1-12 months | |
| 6 Minute walk distance | 1-12 months | |
| NT-proBNP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Braun, MD | Contact | +49 89 4400 | 73052 | Daniel.Braun@med.uni-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Braun, MD | Klinikum der Universität München | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Großhadern University Hospital | München | Bavaria | 81377 | Germany |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 1-12 months |
| MLHFQ | 1-12 months |