Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Tricuspid Valve Regurgitation Clinical Trial

Official title:

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471807
• Other study ID #: 2014-04
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 17, 2023

Study information

• Verified date: February 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 17, 2023
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Device:
• Edwards FORMA Tricuspid Transcatheter Repair System

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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