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

Description

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

Conditions

Mitral Valve Regurgitation

Study Overview

Study Details

Study overview

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

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

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

Condition
Mitral Valve Regurgitation
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Birmingham (UAB), Birmingham, Alabama, United States, 35233

Phoenix

Abrazo Heart Hospital, Phoenix, Arizona, United States, 85018

La Jolla

Scripps Memorial Hospital, La Jolla, California, United States, 92037

Los Angeles

PIH Health Good Samaritan Hospital, Los Angeles, California, United States, 90017

Los Angeles

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States, 90027

Los Angeles

Keck Hospital of the University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

Mountain View

El Camino, Mountain View, California, United States, 94040

San Francisco

Kaiser Permanente San Francisco Medical Center, San Francisco, California, United States, 94118-3100

Stanford

Stanford Hospital and Clinics, Stanford, California, United States, 94305

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

  • * Moderate to severe or severe symptomatic mitral regurgitation
  • * 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
  • * prior transcatheter mitral valve procedure with device currently implanted
  • * anatomic contraindications
  • * prohibitive mitral annular calcification
  • * left ventricular ejection fraction \<25%
  • * need for emergent or urgent surgery
  • * hemodynamic instability

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2036-09-30