Back to resultsTVMR With the Innovalve System Trial - Early Feasibility Study (TWIST-EFS)
Primary Purpose
Mitral Valve Regurgitation (Degenerative or Functional)
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Innovalve MR system
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation (Degenerative or Functional)
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%
Sites / Locations
- Cedars-SinaiRecruiting
- Mayo ClinicRecruiting
- Cleveland ClinicRecruiting
- OhioHealth Research InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
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
Procedural success
NYHA functional class
Six-minute walk test
Quality of life improvement (KCCQ-12)
Reduction in MR grade
Full Information
NCT ID
NCT04919980
First Posted
June 3, 2021
Last Updated
October 3, 2023
Sponsor
Innovalve Bio Medical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04919980
Brief Title
TVMR With the Innovalve System Trial - Early Feasibility Study
Acronym
TWIST-EFS
Official Title
TVMR With the Innovalve System Trial - Early Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
September 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
Yes
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
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
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
Time Frame
Procedure
Title
Procedural success
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)
Time Frame
30 days, 6, 12 months and annually up to 5 years
Title
Reduction in MR 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
Cedars-Sinai
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhairya Patel
Phone
810-919-1331
Email
Dhairya.Patel@cshs.org
First Name & Middle Initial & Last Name & Degree
Mitch Gheorghiu
Phone
310-407-9553
Email
Mitch.Gheorghiu@cshs.org
First Name & Middle Initial & Last Name & Degree
Rajendra Makkar, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
555905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Griffin
Email
griffinii.carl@mayo.edu
First Name & Middle Initial & Last Name & Degree
Chet Rihal, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Tylicki
Phone
216-444-6950
Email
tylicke@ccf.org
First Name & Middle Initial & Last Name & Degree
Samir Kapadia, MD
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katy Monnin
Phone
614-566-5768
Email
katy.monnin@ohiohealth.com
First Name & Middle Initial & Last Name & Degree
Carlos Sanchez, MD
First Name & Middle Initial & Last Name & Degree
Steven Yakubov, MD
12. IPD Sharing Statement
Learn more about this trial
TVMR With the Innovalve System Trial - Early Feasibility Study
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