N/A
Completed N=65
Edwards CLASP TR EFS
Source: ClinicalTrials.gov NCT03745313 ↗Enrolled (actual)
65
Serious AEs
75.4%
Results posted
Oct 2024
Primary outcomePrimary: Composite Major Adverse Event (MAE) Rate — 6 Participants
Summary
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Major Adverse Event (MAE) Rate |
6 | — |
| SECONDARY Device Success |
90 | — |
| SECONDARY Procedural Success |
49 | — |
| SECONDARY Clinical Success |
43 | — |
Eligibility Criteria
Inclusion Criteria
- Severe functional or degenerative TR
- Symptomatic despite medical therapy
- The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair
Exclusion Criteria
- Unsuitable anatomy
- Previous tricuspid valve repair or replacement
- Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Data sourced from ClinicalTrials.gov (NCT03745313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.