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Clinical Trials/NCT05688514
NCT05688514
Completed
Not Applicable

TVMR With the Innovalve System Trial - First In Human Israel

Edwards Lifesciences1 site in 1 country1 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Valve Regurgitation (Degenerative or Functional)
Sponsor
Edwards Lifesciences
Enrollment
1
Locations
1
Primary Endpoint
Absence of implant or delivery related serious adverse events at 30 days
Status
Completed
Last Updated
last year

Overview

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

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
April 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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