TVMR With the Innovalve System Trial - First In Human Israel (TWIST-FIHIL)

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

Study Overview

• Status: Completed
• Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
• Intervention / Treatment: Device: Innovalve MR system

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 5265601
    • The Chaim Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Innovalve TMVR System; MV replacement with Innovalve MR system	Device: Innovalve MR system; Innovalve MR system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of implant or delivery related serious adverse events at 30 days	Absence of implant or delivery related serious adverse events	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA functional class		30 days, 6, 12 months and annually up to 5 years
Six-minute walk test		30 days, 6, 12 months and annually up to 5 years
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
Reduction in Mitral Regurgitation grade		30 days, 6, 12 months and annually up to 5 years
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
Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire		30 days, 6, 12 months and annually up to 5 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): October 6, 2021
• Study Completion (Actual): April 1, 2025

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 15, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: INVL20-01-IL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No