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

April 18, 2025 updated by: Edwards Lifesciences
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
Time Frame: 30 days, 6, 12 months and annually up to 5 years
30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Time Frame: 30 days, 6, 12 months and annually up to 5 years
30 days, 6, 12 months and annually up to 5 years
Procedural success
Time Frame: 30 days

All of the following must be present:

I. Deployment of the device

II. Absence of major device or procedure related serious adverse events, including:

  1. Death
  2. Stroke
  3. Life-threatening bleeding (MVARC scale)
  4. Major vascular complications
  5. Major cardiac structural complications
  6. Stage 2 or 3 acute kidney injury (includes new dialysis)
  7. Myocardial infarction or coronary ischemia requiring PCI or CABG
  8. 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.
  9. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
30 days
Reduction in Mitral Regurgitation grade
Time Frame: 30 days, 6, 12 months and annually up to 5 years
30 days, 6, 12 months and annually up to 5 years
Technical success
Time Frame: Procedure

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
Time Frame: 30 days, 6, 12 months and annually up to 5 years
30 days, 6, 12 months and annually up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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