Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

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.

Conditions

Mitral Stenosis, Mitral Valve Insufficiency

Study Overview

Study Details

Study overview

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.

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

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

Condition
Mitral Stenosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Hospital, Birmingham, Alabama, United States, 35294

Los Angeles

University of Southern California, Los Angeles, California, United States, 90033

Newport Beach

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States, 92663

Palo Alto

Stanford University, Palo Alto, California, United States, 94305

Orlando

AdventHealth Orlando, Orlando, Florida, United States, 32803

Athens

Piedmont Heart Institute, Athens, Georgia, United States, 30606

Atlanta

Piedmont Heart Institute, Atlanta, Georgia, United States, 30309

Carmel

Ascension St. Vincent Heart Center, Carmel, Indiana, United States, 46290

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic, Rochester, Rochester, Minnesota, United States, 55905

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

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Edwards Lifesciences,

Gorav Ailawadi, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2035-12