Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 9
- Primary Endpoint
- Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success(30 days)
- 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))