Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
- Conditions
- Tricuspid Valve Regurgitation
- Interventions
- Device: Edwards FORMA Tricuspid Transcatheter Repair System
- Registration Number
- NCT02471807
- Lead Sponsor
- Edwards Lifesciences
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- ≥ 18 years old
- Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team
- Tricuspid valve/right heart anatomy not suitable for the study device
- Moderate or greater tricuspid valve stenosis
- Severe RV dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System Edwards FORMA Tricuspid Transcatheter Repair System
- Primary Outcome Measures
Name Time Method Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE 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.
- Secondary Outcome Measures
Name Time Method Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success 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)
Device Success : Count and Percentage of Patients Who Experienced Device Success 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 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.
Trial Locations
- Locations (5)
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States