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

Not Applicable

Withdrawn

• Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
• Interventions: Device: Innovalve TMVR system

• Registration Number: NCT05263375
• Lead Sponsor: Innovalve Bio Medical Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2023-06-01
• Primary Completion: 2024-06-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MV replacement with Innovalve TMVR system	Innovalve TMVR system	MV replacement with Innovalve TMVR system

Primary Outcome Measures

Name	Time	Method
Number of patients with implant or delivery related serious adverse events at 30 days	30 days	Number of patients with implant or delivery related serious adverse events at 30 days