TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

Innovalve Bio Medical

Status: Withdrawn

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Treatments: Device: Innovalve TMVR system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05263375

INVL21-02-BE

Details and patient eligibility

About

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

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 <30%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

MV replacement with Innovalve TMVR system

Experimental group

Description:

MV replacement with Innovalve TMVR system

Treatment:

Device: Innovalve TMVR system