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Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
 
Region Sponsors
California - Southern
Medtronic Cardiovascular
 
Acronym KP IRB No.
APOLLO 11750
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
(Adult, Older Adult) Male and Female with histologically confirmed Mitral Valve Regurgitation
 
Purpose
Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device. Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually through 5 years
 
Detailed Description
All-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization.Time Frame: 1 year Composite
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • moderate to severe or severe symptomatic mitral regurgitation
  • candidate for bioprosthetic mitral valve replacement, as determined by heart team
 
Exclusion Criteria
  • 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
  • anatomic contraindications
  • prohibitive mitral annular calcification
  • left ventricular ejection fraction <25% need for emergent or urgent surgery
  • hemodynamic instability

 
Keywords and/or Specific Medical Conditions
  • Cardiovascular Diseases
  • Mitral Valve Insufficiency
  • Heart Diseases
  • Cardiology
  • Heart Valve Diseases
 
KP Clinical Facility
  • Los Angeles (Sunset)
 
Clinical Area
  • Cardiology


Principal Investigator:
Somjot Brar, MD
Contact Information:
- Tiffany Castanon
-626-564-5667
-Los Angeles (Sunset)


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