TVMR With the Innovalve System Trial - First In Human Israel

Mitral Valve Regurgitation (Degenerative or Functional) Clinical Trial

— TWIST-FIHIL  

Official title:

TVMR With the Innovalve System Trial - First In Human Israel

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688514
• Other study ID #: INVL20-01-IL
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 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

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: 10
• Est. completion date: October 1, 2028
• Est. primary completion date: October 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
Israel	The Chaim Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Innovalve Bio Medical Ltd.

Country where clinical trial is conducted

Israel, 

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	All of the below: i. Absence of procedural mortality; and ii. Successful access, delivery, and retrieval of the device delivery system; and iii. Successful deployment and correct positioning of the first intended device; and iv. Freedom from emergency surgery or reintervention related to the device or access procedure.	Procedure
Secondary	Procedural success	All of the following must be present: I. Deployment of the device; II. Absence of major device or procedure related serious adverse events, including: Death; Stroke; Life-threatening bleeding (MVARC scale); Major vascular complications; Major cardiac structural complications; Stage 2 or 3 acute kidney injury (includes new dialysis); Myocardial infarction or coronary ischemia requiring PCI or CABG; Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for 48 h.; Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention	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) Kensas City Cardiomyopathy Questionnaire		30 days, 6, 12 months and annually up to 5 years
Secondary	Reduction in Mitral Regurgitation grade		30 days, 6, 12 months and annually up to 5 years