Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Conditions
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Tricuspid Valve Regurgitation

Intervention / Treatment
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* Device: Edwards FORMA Tricuspid Transcatheter Repair System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Edwards FORMA Tricuspid Transcatheter Repair System<br>Edwards FORMA Tricuspid Transcatheter Repair System | Device: Edwards FORMA Tricuspid Transcatheter Repair System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success : Count and Percentage of Patients Who Experienced Device Success | 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. | Intraprocedural | 
| Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success | 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. | Discharge (2-8 days) | 
| Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success | 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) | 30 days |