N/A
N=34
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Tricuspid Valve Regurgitation
Bottom Line
View on ClinicalTrials.gov: NCT02471807 ↗Enrolled (actual)
34
Serious AEs
97.1%
Results posted
Jan 2022
Primary outcome: Primary: Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE — 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Edwards FORMA Tricuspid Transcatheter Repair System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Edwards Lifesciences
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE |
10 | — |
| SECONDARY Device Success : Count and Percentage of Patients Who Experienced Device Success |
32 | — |
| SECONDARY Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success |
12 | — |
| SECONDARY Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success |
11 | — |
Summary
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.
Eligibility Criteria
Inclusion Criteria
- ≥ 18 years old
- Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team
Exclusion Criteria
- Tricuspid valve/right heart anatomy not suitable for the study device
- Moderate or greater tricuspid valve stenosis
- Severe RV dysfunction
Data sourced from ClinicalTrials.gov (NCT02471807). 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.