Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
1 other identifier
interventional
34
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedResults Posted
Study results publicly available
January 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2023
CompletedMarch 28, 2023
February 1, 2023
3.5 years
June 11, 2015
October 1, 2021
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
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.
30 days
Secondary Outcomes (3)
Device Success : Count and Percentage of Patients Who Experienced Device Success
Intraprocedural
Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success
Discharge (2-8 days)
Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success
30 days
Study Arms (1)
Edwards FORMA Tricuspid Transcatheter Repair System
EXPERIMENTALEdwards FORMA Tricuspid Transcatheter Repair System
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years old
- Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team
You may not qualify if:
- Tricuspid valve/right heart anatomy not suitable for the study device
- Moderate or greater tricuspid valve stenosis
- Severe RV dysfunction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ted Feldman, MD
- Organization
- Edwards Lifesciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 15, 2015
Study Start
December 1, 2015
Primary Completion
June 1, 2019
Study Completion
January 17, 2023
Last Updated
March 28, 2023
Results First Posted
January 6, 2022
Record last verified: 2023-02