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

Tracking Information
First Submitted Date ICMJE	August 3, 2017
First Posted Date ICMJE	August 8, 2017
Last Update Posted Date	January 11, 2019
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: April 10, 2018)	all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization [ Time Frame: 1 year ]; composite
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT03242642 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 11, 2017)	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
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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)
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 11, 2017)	1380
Original Enrollment ICMJE	Not Provided
Estimated Study Completion Date	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	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Kristin Boulware 763-514-9809 rs.tmvrpivotaltrial@medtronic.com
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	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	October 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP