Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
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ClinicalTrials.gov Identifier: NCT02471807 |
Recruitment Status :
Active, not recruiting
First Posted : June 15, 2015
Results First Posted : January 6, 2022
Last Update Posted : January 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tricuspid Valve Regurgitation | Device: Edwards FORMA Tricuspid Transcatheter Repair System | Not Applicable |
The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System 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.
Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System |
Study Start Date : | December 2015 |
Actual Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | January 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Edwards FORMA Tricuspid Transcatheter Repair System
Edwards FORMA Tricuspid Transcatheter Repair System
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Device: Edwards FORMA Tricuspid Transcatheter Repair System |
- Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE [ Time Frame: 30 days ]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.
- Device Success : Count and Percentage of Patients Who Experienced Device Success [ Time Frame: Intraprocedural ]Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
- Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success [ Time Frame: Discharge (2-8 days) ]Device success with evidence of TR reduction as evidenced by a relative reduction in EROA of ≥ 30% from baseline to discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge.
- Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success [ Time Frame: 30 days ]Procedural success without MAEs at 30 days. (MAEs: cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention and major access site and vascular complications)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471807
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Georgia | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New Jersey | |
Morristown Medical Center | |
Morristown, New Jersey, United States, 07960 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Documents provided by Edwards Lifesciences:
Responsible Party: | Edwards Lifesciences |
ClinicalTrials.gov Identifier: | NCT02471807 |
Other Study ID Numbers: |
2014-04 |
First Posted: | June 15, 2015 Key Record Dates |
Results First Posted: | January 6, 2022 |
Last Update Posted: | January 6, 2022 |
Last Verified: | December 2021 |
Tricuspid Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |