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

Primary Purpose

Mitral Valve Regurgitation (Degenerative or Functional)

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Innovalve MR system
Sponsored by
Innovalve Bio Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation (Degenerative or Functional)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • The Chaim Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Innovalve TMVR System

Arm Description

MV replacement with Innovalve MR system

Outcomes

Primary Outcome Measures

Absence of implant or delivery related serious adverse events at 30 days
Absence of implant or delivery related serious adverse events

Secondary Outcome Measures

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.
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
NYHA functional class
Six-minute walk test
Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire
Reduction in Mitral Regurgitation grade

Full Information

First Posted
December 22, 2022
Last Updated
January 15, 2023
Sponsor
Innovalve Bio Medical Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05688514
Brief Title
TVMR With the Innovalve System Trial - First In Human Israel
Acronym
TWIST-FIHIL
Official Title
TVMR With the Innovalve System Trial - First In Human Israel
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovalve Bio Medical Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation (Degenerative or Functional)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Innovalve TMVR System
Arm Type
Experimental
Arm Description
MV replacement with Innovalve MR system
Intervention Type
Device
Intervention Name(s)
Innovalve MR system
Intervention Description
Innovalve MR system
Primary Outcome Measure Information:
Title
Absence of implant or delivery related serious adverse events at 30 days
Description
Absence of implant or delivery related serious adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Technical success
Description
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.
Time Frame
Procedure
Title
Procedural success
Description
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
Time Frame
30 days
Title
NYHA functional class
Time Frame
30 days, 6, 12 months and annually up to 5 years
Title
Six-minute walk test
Time Frame
30 days, 6, 12 months and annually up to 5 years
Title
Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire
Time Frame
30 days, 6, 12 months and annually up to 5 years
Title
Reduction in Mitral Regurgitation grade
Time Frame
30 days, 6, 12 months and annually up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director Clinical Affairs
Phone
+972-3-5308058
Email
clinicaltrials@innovalemed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Ivenshitz, PhD
Phone
+972-53-9516947
Email
miriam@innovalvemed.com
Facility Information:
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Guetta, MD

12. IPD Sharing Statement

Learn more about this trial

TVMR With the Innovalve System Trial - First In Human Israel

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