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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242642
Recruitment Status : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : April 29, 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 April 29, 2020
Actual Study Start Date  ICMJE October 23, 2017
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Randomized Cohort [ Time Frame: 1 year ]
    all-cause mortality, disabling stroke, reoperation or reintervention and cardiovascular hospitalization composite
  • Single-Arm Primary Cohort [ Time Frame: 1 year ]
    all-cause mortality, disabling stroke, reoperation or reintervention and cardiovascular hospitalization composite
  • Single-Arm 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, 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel 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: Surgical Mitral Valve Replacement (SMVR)
    mitral valve replacement
Study Arms  ICMJE
  • 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)
  • Experimental: Non-Surgical Candidate - Mitral Annular Calcification -TMVR
    Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
    Intervention: 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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
1600
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE 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 April 2020

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