Back to resultsTVMR With the Innovalve System Trial - Pilot Study in Italy (TWIST-PILOT-IT)
Primary Purpose
Mitral Valve Regurgitation (Degenerative or Functional)
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Innovalve TMVR 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 <30%
Sites / Locations
- HumanitasRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MV replacement with Innovalve MR 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 at 30 days
Secondary Outcome Measures
Full Information
NCT ID
NCT05010746
First Posted
August 11, 2021
Last Updated
January 22, 2023
Sponsor
Innovalve Bio Medical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05010746
Brief Title
TVMR With the Innovalve System Trial - Pilot Study in Italy
Acronym
TWIST-PILOT-IT
Official Title
TVMR With the Innovalve System Trial - Pilot Study in Italy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 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
5. Study Description
Brief Summary
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
MV replacement with Innovalve MR system
Arm Type
Experimental
Arm Description
MV replacement with Innovalve MR system
Intervention Type
Device
Intervention Name(s)
Innovalve TMVR system
Intervention Description
Innovalve TMVR 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 at 30 days
Time Frame
30 days
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 <30%
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
Humanitas
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melania Scatturin
Phone
+390282247333
Email
melania.scatturin@humanitas.it
First Name & Middle Initial & Last Name & Degree
Antonio Colombo, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TVMR With the Innovalve System Trial - Pilot Study in Italy
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