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

Mitral Valve Regurgitation (Degenerative or Functional) Clinical Trial

Official title:

TVMR With the Innovalve System Trial - Pilot Study in Belgium

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05263375
• Other study ID #: INVL21-02-BE
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2022
• Source: Innovalve Bio Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation (Degenerative or Functional)

Intervention

Device:
• Innovalve TMVR system
Innovalve TMVR system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Innovalve Bio Medical Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with implant or delivery related serious adverse events at 30 days	Number of patients with implant or delivery related serious adverse events at 30 days	30 days