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

• Sponsor: Innovalve Bio Medical Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05263375
• Collaborator: (none)
• Enrollment: 10
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Regurgitation (Degenerative or Functional)	Device: Innovalve TMVR system	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: TVMR With the Innovalve System Trial - Pilot Study in Belgium
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MV replacement with Innovalve TMVR system MV replacement with Innovalve TMVR system	Device: Innovalve TMVR system; Innovalve TMVR system

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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%

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Innovalve Bio Medical Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Innovalve Bio Medical Ltd.
• ClinicalTrials.gov Identifier: NCT05263375
• Other Study ID Numbers: INVL21-02-BE
• First Posted: Mar 2, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

No Results Posted as of Aug 12, 2022