CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Edwards FORMA Tricuspid Transcatheter Repair Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02471807
NCT02471807N/ACompleted
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Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Edwards Lifesciences·interventional·Posted Jun 15, 2015·Updated Mar 28, 2023

In Brief

A clinical study evaluating Edwards FORMA Tricuspid Transcatheter Repair System for Tricuspid Valve Regurgitation. Completed, enrolled 34 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTricuspid Valve Regurgitation
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 15, 2015
Enrollment StartDec 1, 2015
Primary CompletionJun 1, 2019
Study CompletionJan 17, 2023
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.0 years ago

Interventions

Edwards FORMA Tricuspid Transcatheter Repair Systemdevice