TVMR With the Innovalve System Trial - Early Feasibility Study

Description

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

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Study Overview

Study Details

Study overview

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

TVMR With the Innovalve System Trial - Early Feasibility Study

TVMR With the Innovalve System Trial - Early Feasibility Study

Condition
Mitral Valve Regurgitation (Degenerative or Functional)
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai, Los Angeles, California, United States, 90048

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 555905

New York

NewYork-Presbyterian / Columbia University, New York, New York, United States, 10032

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Columbus

OhioHealth Research Institute, Columbus, Ohio, United States, 43214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Clinically significant, symptomatic mitral regurgitation
  • * High risk for open-heart surgery
  • * Meets anatomical criteria
  • * Unsuitable anatomy
  • * Patient is inoperable
  • * EF\<25%

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Innovalve Bio Medical Ltd.,

Study Record Dates

2028-09-01