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NCT02471807 · ClinicalTrials.gov registry record · NA
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
A NA study, sponsored by Edwards Lifesciences.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT02471807: Completed NA study, sponsored by Edwards Lifesciences.
NCT02471807 is a NA study that has completed, run by Edwards Lifesciences. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02471807, a NA study, has completed, sponsored by Edwards Lifesciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study 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.
Primary Outcome
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention for study device related complications or on the previously implanted study device, and major access site and vascular complications requiring intervention at 30 days.
Interventions
- DEVICE Edwards FORMA Tricuspid Transcatheter Repair System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-12 |
| Est. Completion | 2023-01-17 |
| Phase | NA |
What the finished NCT02471807 record still lists
NCT02471807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Edwards FORMA Tricuspid Transcatheter Repair System is the first listed.
NCT02471807 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02471807 about?
NCT02471807 is a clinical study titled "Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System". 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...
What is the current status of trial NCT02471807?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2015-12. Estimated completion is 2023-01-17.
What interventions are being tested in trial NCT02471807?
The interventions under investigation include: Edwards FORMA Tricuspid Transcatheter Repair System (DEVICE).
Who is sponsoring clinical trial NCT02471807?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02471807's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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