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TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

Primary Purpose

Mitral Valve Regurgitation (Degenerative or Functional)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Innovalve TMVR 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 <30%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MV replacement with Innovalve TMVR system

    Arm Description

    MV replacement with Innovalve TMVR system

    Outcomes

    Primary Outcome Measures

    Number of patients with implant or delivery related serious adverse events at 30 days
    Number of patients with implant or delivery related serious adverse events at 30 days

    Secondary Outcome Measures

    Full Information

    First Posted
    February 21, 2022
    Last Updated
    August 11, 2022
    Sponsor
    Innovalve Bio Medical Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05263375
    Brief Title
    TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
    Official Title
    TVMR With the Innovalve System Trial - Pilot Study in Belgium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2025 (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 TMVR system
    Arm Type
    Experimental
    Arm Description
    MV replacement with Innovalve TMVR system
    Intervention Type
    Device
    Intervention Name(s)
    Innovalve TMVR system
    Intervention Description
    Innovalve TMVR system
    Primary Outcome Measure Information:
    Title
    Number of patients with implant or delivery related serious adverse events at 30 days
    Description
    Number of patients with 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%

    12. IPD Sharing Statement

    Learn more about this trial

    TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

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