Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Edwards Lifesciences34 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tricuspid Valve Regurgitation

Interventions

Edwards FORMA Tricuspid Transcatheter Repair SystemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years old 2. Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team Exclusion Criteria: 1. Tricuspid valve/right heart anatomy not suitable for the study device 2. Moderate or greater tricuspid valve stenosis 3. Severe RV dysfunction

Locations (5)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

Morristown Medical Center

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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)

Time frame: 30 days

Data from ClinicalTrials.gov

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