Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

ClinicalTrials.gov ID: NCT02471807

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT02471807
Recruitment status: Completed
Study type: Interventional
Phase: Not applicable
Lead sponsor: Edwards Lifesciences; Industry
Enrollment: 34 participants

Conditions and interventions

Conditions

Tricuspid Valve Regurgitation

Interventions

Edwards FORMA Tricuspid Transcatheter Repair System Device

Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 2015 (Type not available)
Primary completion: Jun 2019 (Actual)
Completion: Jan 17, 2023 (Actual)
Last update posted: Mar 28, 2023

2015 – 2023

United States locations

U.S. sites: 5
U.S. states: 5
U.S. cities: 5

Facility	City	State	ZIP	Site status
Cedars-Sinai Medical Center	Los Angeles	California	90048	—
Emory University Hospital	Atlanta	Georgia	30322	—
Mayo Clinic	Rochester	Minnesota	55905	—
Morristown Medical Center	Morristown	New Jersey	07960	—
Columbia University Medical Center	New York	New York	10032	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02471807, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 28, 2023 · Synced Nov 15, 2026