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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 : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mitral Valve Regurgitation Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) Device: Surgical Mitral Valve Replacement (SMVR) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2025

Arm Intervention/treatment
Experimental: Surgical Candidate - TMVR
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
mitral valve replacement

Active Comparator: Surgical Candidate - SMVR
Treatment of mitral regurgitation with conventional Surgical Mitral Valve Replacement (SMVR)
Device: Surgical Mitral Valve Replacement (SMVR)
mitral valve replacement

Experimental: Non-Surgical Candidate - TMVR
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
mitral valve replacement




Primary Outcome Measures :
  1. all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization [ Time Frame: 1 year ]
    composite


Secondary Outcome Measures :
  1. 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

  2. Change in New York Heart Association Class [ Time Frame: 1 year ]
    change in NYHA Class

  3. Quality of Life Improvement [ Time Frame: 30 days (SF-12) and 1yr (KCCQ) ]
    measured by SF-12 and KCCQ

  4. Echocardiographic assessments of degree mitral valve regurgitation [ Time Frame: 1 year ]
    measured by echocardiography

  5. Days alive out of hospital (all hospitalizations) [ Time Frame: 1 year ]
    all hospitalizations

  6. Cardiovascular hospitalizations [ Time Frame: 1 year ]
    cardiovascular hospitalizations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242642


Contacts
Contact: Kristin Boulware 763-514-9809 rs.tmvrpivotaltrial@medtronic.com

  Show 40 Study Locations
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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

Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT03242642     History of Changes
Other Study ID Numbers: MDT17022TMV001
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: April 2018

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

Keywords provided by Medtronic Cardiovascular:
Heart disease
valve disease
heart valve disease
mitral regurgitation
cardiovascular disease
mitral insufficiency

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases