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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 : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Tracking Information
First Submitted Date  ICMJE August 3, 2017
First Posted Date  ICMJE August 8, 2017
Last Update Posted Date November 30, 2020
Actual Study Start Date  ICMJE October 23, 2017
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2020)
  • Primary Cohort [ Time Frame: 1 year ]
    all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite
  • MAC Cohort [ Time Frame: 1 year ]
    all-cause mortality and heart failure hospitalization composite
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding [ Time Frame: 30 days or hospital discharge (whichever is later) ]
    Composite
  • Change in New York Heart Association Class [ Time Frame: 30 days ]
    change in NYHA Class
  • Quality of Life Improvement [ Time Frame: 30 days (SF-12) and 3 months (KCCQ) ]
    measured by SF-12 and KCCQ
  • Echocardiographic assessments of degree mitral valve regurgitation [ Time Frame: 1 year ]
    measured by echocardiography
  • Cardiovascular hospitalizations [ Time Frame: 1 year ]
    cardiovascular hospitalizations
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation
Official Title  ICMJE Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Brief Summary Multi-center, global, prospective, non-randomize, interventional, pre-market trial. All subjects enrolled with receive the study device
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mitral Valve Regurgitation
Intervention  ICMJE
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    mitral valve replacement
  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Study Arms  ICMJE
  • Experimental: Primary Cohort- TMVR
    Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
    Interventions:
    • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
  • Experimental: Mitral Annular Calcification -TMVR
    Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
    Interventions:
    • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
    • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2020)
1150
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE October 2028
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • moderate to severe or severe symptomatic mitral regurgitation
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject may not be optimally treated with approved transcatheter repair or conventional mitral valve surgery

Exclusion Criteria:

  • prior transcatheter mitral valve procedure with device currently implanted
  • anatomic contraindications
  • prohibitive mitral annular calcification
  • left ventricular ejection fraction <30%
  • need for emergent or urgent surgery
  • hemodynamic instability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samuel Starkman 7635149743 rs.tmvrpivotaltrial@medtronic.com
Listed Location Countries  ICMJE Denmark,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242642
Other Study ID Numbers  ICMJE MDT17022TMV001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Cardiovascular
Study Sponsor  ICMJE Medtronic Cardiovascular
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Cardiovascular
Verification Date November 2020

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