TVMR With the INNOVALVE System Trial - Early Feasibility Study

Edwards Lifesciences27 sites in 1 country65 target enrollmentSeptember 1, 2022

ConditionsMitral Valve Regurgitation (Degenerative or Functional)

InterventionsINNOVALVE system

Overview

Phase: Not Applicable
Intervention: INNOVALVE system
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Sponsor: Edwards Lifesciences
Enrollment: 65
Locations: 27
Primary Endpoint: Absence of implant or delivery related serious adverse events at 30 Days
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Study to evaluate the safety and performance of the INNOVALVE 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 system

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

July 1, 2031

Last Updated

3 months ago

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

Arms & Interventions

Treatment

MV replacement with INNOVALVE system

Intervention: INNOVALVE system

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

Technical success(Procedure)
Procedural success(30 days)
Quality of life improvement (KCCQ-12)(30 days, 6, 12 months and annually up to 5 years)
Reduction in MR grade(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)