RECRUITING

TVMR With the INNOVALVE System Trial - Early Feasibility Study

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Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study to evaluate the safety and performance of the INNOVALVE system

Official Title

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Quick Facts

Study Start:2022-09-01
Study Completion:2031-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04919980

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinically significant, symptomatic mitral regurgitation
  2. * High risk for open-heart surgery
  3. * Meets anatomical criteria
  1. * Unsuitable anatomy
  2. * Patient is inoperable
  3. * EF\<25%

Contacts and Locations

Study Contact

TMTT Clinical
CONTACT
(949) 250-2500
TMTT_Clinical@edwards.com

Principal Investigator

Chet Rihal
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Cedars-Sinai
Los Angeles, California, 90048
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 555905
United States
Cornell
New York, New York, 10021
United States
NewYork-Presbyterian / Columbia University
New York, New York, 10032
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
OhioHealth Research Institute
Columbus, Ohio, 43214
United States
Oregon Health & Science Universtiy
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • Chet Rihal, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-01
Study Completion Date2031-07-01

Study Record Updates

Study Start Date2022-09-01
Study Completion Date2031-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Mitral Valve Regurgitation (Degenerative or Functional)