ACTIVE_NOT_RECRUITING

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

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Conditions

Mitral StenosisMitral Valve InsufficiencyMitral Valve Replacement

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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

Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.

Official Title

A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Quick Facts

Study Start:2023-01-11
Study Completion:2035-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05526560

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. * 18 years or older at the time of informed consent
  2. * Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
  3. * Provides written informed consent
  4. * Willingness to follow protocol requirements
  1. * Active endocarditis 3 months prior to the procedure
  2. * Stage 4 renal disease or requiring dialysis
  3. * Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
  4. * High predicted risk of mortality prior to procedure
  5. * Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of \> 8 or
  6. * Surgeon estimated risk of mortality of \> 8

Contacts and Locations

Principal Investigator

Gorav Ailawadi, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
Stanford University
Palo Alto, California, 94305
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Piedmont Heart Institute
Athens, Georgia, 30606
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Ascension St. Vincent Heart Center
Carmel, Indiana, 46290
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
United States
Washington University Barnes-Jewish Hospital
St Louis, Missouri, 63110
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Weill Cornell Medicine
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27703
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15232
United States
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
United States
Ascension Saint Thomas
Nashville, Tennessee, 37205
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • Gorav Ailawadi, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2023-01-11
Study Completion Date2035-12

Study Record Updates

Study Start Date2023-01-11
Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

  • Mitral Valve Replacement

Additional Relevant MeSH Terms

  • Mitral Stenosis
  • Mitral Valve Insufficiency