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

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ClinicalTrials.gov Identifier: NCT03242642
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

August 3, 2017
August 8, 2017
January 11, 2019
October 23, 2017
October 2021   (Final data collection date for primary outcome measure)
all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization [ Time Frame: 1 year ]
composite
Not Provided
Complete list of historical versions of study NCT03242642 on ClinicalTrials.gov Archive Site
  • all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation (or reintervention) for any reason, and major bleeding [ Time Frame: 30 days or hospital discharge (whichever is later) ]
    Composite
  • Change in New York Heart Association Class [ Time Frame: 1 year ]
    change in NYHA Class
  • Quality of Life Improvement [ Time Frame: 30 days (SF-12) and 1yr (KCCQ) ]
    measured by SF-12 and KCCQ
  • Echocardiographic assessments of degree mitral valve regurgitation [ Time Frame: 1 year ]
    measured by echocardiography
  • Days alive out of hospital (all hospitalizations) [ Time Frame: 1 year ]
    all hospitalizations
  • Cardiovascular hospitalizations [ Time Frame: 1 year ]
    cardiovascular hospitalizations
Not Provided
Not Provided
Not Provided
 
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Mitral Valve Regurgitation
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    mitral valve replacement
  • Device: Surgical Mitral Valve Replacement (SMVR)
    mitral valve replacement
  • Experimental: Surgical Candidate - TMVR
    Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
    Intervention: Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
  • Active Comparator: Surgical Candidate - SMVR
    Treatment of mitral regurgitation with conventional Surgical Mitral Valve Replacement (SMVR)
    Intervention: Device: Surgical Mitral Valve Replacement (SMVR)
  • Experimental: Non-Surgical Candidate - TMVR
    Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
    Intervention: Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1380
Not Provided
October 2025
October 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Kristin Boulware 763-514-9809 rs.tmvrpivotaltrial@medtronic.com
United States
 
 
NCT03242642
MDT17022TMV001
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Not Provided
Medtronic Cardiovascular
Medtronic Cardiovascular
Not Provided
Study Chair: Michael Mack, MD Baylor Scott & White Hospital
Principal Investigator: David Adams, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Martin Leon, MD New York Presbyterian Hospital/Columbia University Medical Center
Medtronic Cardiovascular
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP