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 : 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

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

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

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

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

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