TVMR With the Innovalve System Trial – First In Human Israel

Overview

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

Full Title of Study: “TVMR With the Innovalve System Trial – First In Human Israel”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1, 2024

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

Interventions

  • Device: Innovalve MR system
    • Innovalve MR system

Arms, Groups and Cohorts

  • Experimental: Innovalve TMVR System
    • MV replacement with Innovalve MR system

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Technical success
    • Time Frame: Procedure
    • 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
    • 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
  • NYHA functional class
    • Time Frame: 30 days, 6, 12 months and annually up to 5 years
  • Six-minute walk test
    • Time Frame: 30 days, 6, 12 months and annually up to 5 years
  • Quality of life improvement (KCCQ-12) Kensas City Cardiomyopathy Questionnaire
    • Time Frame: 30 days, 6, 12 months and annually up to 5 years
  • Reduction in Mitral Regurgitation grade
    • Time Frame: 30 days, 6, 12 months and annually up to 5 years

Participating in This Clinical Trial

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%

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Innovalve Bio Medical Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Director Clinical Affairs, +972-3-5308058, clinicaltrials@innovalemed.com

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