RECRUITING

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

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Conditions

Mitral Valve RegurgitationHeart diseasevalve diseaseheart valve diseasemitral regurgitationcardiovascular diseasemitral insufficiency

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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

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Official Title

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

Quick Facts

Study Start:2017-10-23
Study Completion:2036-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03242642

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. * Moderate to severe or severe symptomatic mitral regurgitation
  2. * Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention
  1. * prior transcatheter mitral valve procedure with device currently implanted
  2. * anatomic contraindications
  3. * prohibitive mitral annular calcification
  4. * left ventricular ejection fraction \<25%
  5. * need for emergent or urgent surgery
  6. * hemodynamic instability

Contacts and Locations

Study Contact

Megan Wilder Fredrickson
CONTACT
612-469-1749
rs.tmvrpivotaltrial@medtronic.com

Principal Investigator

Michael Mack, MD
STUDY_CHAIR
Baylor Scott & White Hospital
David Adams, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Martin Leon, MD
PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital/Columbia University Medical Center

Study Locations (Sites)

University of Alabama Birmingham (UAB)
Birmingham, Alabama, 35233
United States
Abrazo Heart Hospital
Phoenix, Arizona, 85018
United States
Scripps Memorial Hospital
La Jolla, California, 92037
United States
PIH Health Good Samaritan Hospital
Los Angeles, California, 90017
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Keck Hospital of the University of Southern California
Los Angeles, California, 90033
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
El Camino
Mountain View, California, 94040
United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94118-3100
United States
Stanford Hospital and Clinics
Stanford, California, 94305
United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360-1847
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
JFK Medical Center
Atlantis, Florida, 33462
United States
Morton Plant
Clearwater, Florida, 33756
United States
HealthPark Medical Center
Fort Myers, Florida, 33908
United States
North Florida Regional Medical Center
Gainesville, Florida, 32605
United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207
United States
University of South Florida
Tampa, Florida, 33606
United States
Emory University
Atlanta, Georgia, 30308
United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Mercy Medical Center
Des Moines, Iowa, 50314
United States
The University of Kansas Hospital
Kansas City, Kansas, 66160
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Ascension St. John Hospital
Detroit, Michigan, 48236
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, 55455
United States
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110-1003
United States
Providence St Patrick
Missoula, Montana, 59802-4008
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
Jersey Shore University Medical Center
Neptune, New Jersey, 07753
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
NYU Langone Medical Center
New York, New York, 10016
United States
The Mount Sinai Hospital
New York, New York, 10029
United States
New York-Presbyterian Hospital Columbia University Medical Center
New York, New York, 10032
United States
Montefiore Medical Center
New York, New York, 10467-2401
United States
Saint Francis Hospital
Roslyn, New York, 11576
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
The Christ Hospital
Cincinnati, Ohio, 45219-2906
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
UPMC Pinnacle Harrisburg Campus
Harrisburg, Pennsylvania, 17101
United States
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
United States
Heart Hospital of Austin
Austin, Texas, 78756
United States
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, 75246
United States
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
Houston, Texas, 77030
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Baylor Scott & White Health (The Heart Hospital Baylor Plano)
Plano, Texas, 75093
United States
Methodist Hospital
San Antonio, Texas, 78229
United States
The University of Vermont Medical Center
Burlington, Vermont, 05401-1473
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908
United States
Inova Fairfax Hospital
Fairfax, Virginia, 22042
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507-1904
United States
Saint Mary's Hospital/Bon Secours
Richmond, Virginia, 23226
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
United States
Winchester Medical Center
Winchester, Virginia, 22601
United States
The Swedish Medical Center Cherry Hill
Seattle, Washington, 98122
United States
University of Washington
Seattle, Washington, 98195
United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Medtronic Cardiovascular

  • Michael Mack, MD, STUDY_CHAIR, Baylor Scott & White Hospital
  • David Adams, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Martin Leon, MD, PRINCIPAL_INVESTIGATOR, New York Presbyterian Hospital/Columbia University Medical Center

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 Date2017-10-23
Study Completion Date2036-09-30

Study Record Updates

Study Start Date2017-10-23
Study Completion Date2036-09-30

Terms related to this study

Keywords Provided by Researchers

  • Heart disease
  • valve disease
  • heart valve disease
  • mitral regurgitation
  • cardiovascular disease
  • mitral insufficiency

Additional Relevant MeSH Terms

  • Mitral Valve Regurgitation