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Completed

NCT Number: NCT05682066

TVMR With the Innovalve System Trial - Pilot in Georgia

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

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Key information

Conditions

Mitral Valve Regurgitation (Degenerative or Functional) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

About this study

The study is a multi-center, First-In-Human, prospective, single pilot study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Innovalve MR system

Device

Innovalve MR system

Primary outcomes

  1. 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

Secondary outcomes

  1. Technical success

    Time frame: Procedure

    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.

  2. 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:

    • 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

  3. NYHA functional class

    Time frame: 30 days, 6, 1 year

  4. Six-minute walk test

    Time frame: 30 days, 6, 1 year

  5. Quality of life improvement (KCCQ-12) Kansas City Cardiomyopathy Questionnaire

    Time frame: 30 days, 6, 1 year

  6. Reduction in Mitral Regurgitation grade

    Time frame: 30 days, 6, 1 year

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Acronym: TWIST-PILOT-GE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2023
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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