TVMR With the Innovalve System Trial - Early Feasibility Study

Mitral Valve Regurgitation (Degenerative or Functional) Clinical Trial

— TWIST-EFS  

Official title:

TVMR With the Innovalve System Trial - Early Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919980
• Other study ID #: INVL20-01-USA
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: September 1, 2028

Study information

• Verified date: November 2023
• 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

Description:

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2028
• Est. primary completion date: September 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<25%

Related Conditions & MeSH terms

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

Intervention

Device:
• Innovalve MR system
Innovalve MR system

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Cedars-Sinai	Los Angeles	California
United States	NewYork-Presbyterian / Columbia University	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Innovalve Bio Medical Ltd.

Country where clinical trial is conducted

United States, 

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	30 days
Secondary	Technical success		Procedure
Secondary	Procedural success		30 days
Secondary	NYHA functional class		30 days, 6, 12 months and annually up to 5 years
Secondary	Six-minute walk test		30 days, 6, 12 months and annually up to 5 years
Secondary	Quality of life improvement (KCCQ-12)		30 days, 6, 12 months and annually up to 5 years
Secondary	Reduction in MR grade		30 days, 6, 12 months and annually up to 5 years