TVMR With the Innovalve System Trial - Early Feasibility Study (TWIST-EFS)

Edwards Lifesciences

Status: Enrolling

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Treatments: Device: Innovalve MR system

Study type: Interventional

Funder types: Industry

Identifiers

NCT04919980

2024-13

Details and patient eligibility

About

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

Full 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

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Treatment

Experimental group

Description:

MV replacement with Innovalve MR system

Treatment:

Device: Innovalve MR system