TVMR With the Innovalve System Trial - First In Human Israel

Edwards Lifesciences1 site in 1 country1 target enrollmentOctober 1, 2021

ConditionsMitral Valve Regurgitation (Degenerative or Functional)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Sponsor: Edwards Lifesciences
Enrollment: 1
Locations: 1
Primary Endpoint: Absence of implant or delivery related serious adverse events at 30 days
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed Description

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Registry

clinicaltrials.gov

Start Date

October 1, 2021

End Date

April 1, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinically significant, symptomatic mitral regurgitation
•High risk for open-heart surgery
•Meets anatomical criteria

Exclusion Criteria

•Unsuitable anatomy
•Patient is inoperable

Outcomes

Primary Outcomes

Absence of implant or delivery related serious adverse events at 30 days

Time Frame: 30 days

Absence of implant or delivery related serious adverse events

Secondary Outcomes

Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire(30 days, 6, 12 months and annually up to 5 years)
NYHA functional class(30 days, 6, 12 months and annually up to 5 years)
Six-minute walk test(30 days, 6, 12 months and annually up to 5 years)
Technical success(Procedure)
Procedural success(30 days)
Reduction in Mitral Regurgitation grade(30 days, 6, 12 months and annually up to 5 years)