N/A
N=65
Edwards CLASP TR EFS
Tricuspid Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT03745313 ↗Enrolled (actual)
65
Serious AEs
75.4%
Results posted
Oct 2024
Primary outcome: Primary: Composite Major Adverse Event (MAE) Rate — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Edwards PASCAL Transcatheter Valve Repair System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- May 2021
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 | — |
Summary
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
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.