TVMR With the Innovalve System Trial - Pilot Study in Italy

Mitral Valve Regurgitation (Degenerative or Functional) Clinical Trial

— TWIST-PILOT-IT  

Official title:

TVMR With the Innovalve System Trial - Pilot Study in Italy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010746
• Other study ID #: INVL20-01-IT
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2028

Study information

• Verified date: March 2024
• Source: Innovalve Bio Medical Ltd.
• Contact: Director Clinical Affairs
• Phone: +972-3-5308058
• Email: clinicaltrials[@]innovalemed.com
• 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: Recruiting
• Enrollment: 10
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2025
• 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
Italy	Humanitas	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Innovalve Bio Medical Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

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