TVMR With the Innovalve System Trial - Early Feasibility Study

Not Applicable

Recruiting

• Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

• Registration Number: NCT04919980
• Lead Sponsor: Edwards Lifesciences

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

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-09
• Study Start: 2022-09-01
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-21
• Last Update Posted: 2025-08-28
• Primary Completion: 2026-07-01
• Study Completion: 2031-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

• Unsuitable anatomy
• Patient is inoperable
• EF<25%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
NYHA functional class	30 days, 3, 6, 12 months and annually up to 5 years
Six-minute walk test	30 days, 3, 6, 12 months and annually up to 5 years
Reduction in MR grade	30 days, 3, 6, 12 months and annually up to 5 years
Technical success	Procedure
Procedural success	30 days
Quality of life improvement (KCCQ-12)	30 days, 3, 6, 12 months and annually up to 5 years

Trial Locations

Locations (12)

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

University of Michigan Hospital and Health Systems; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Cornell; 🇺🇸 New York, New York, United States

NewYork-Presbyterian / Columbia University; 🇺🇸 New York, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

OhioHealth Research Institute; 🇺🇸 Columbus, Ohio, United States

Oregon Health & Science Universtiy; 🇺🇸 Portland, Oregon, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

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