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

March 25, 2024 updated by: Medtronic Cardiovascular

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

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Recruiting
        • Royal Columbian Hospital
        • Principal Investigator:
          • Khan Razi
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital
        • Principal Investigator:
          • Wood David
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital
        • Principal Investigator:
          • Neil Fam
        • Principal Investigator:
          • Gianluigi Bisleri
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Andrew Czarnecki
        • Principal Investigator:
          • Gideon Cohen
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montreal Heart Insitute
        • Principal Investigator:
          • Anita Asgar
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Glen Royal Victoria Hospital
        • Principal Investigator:
          • Nicolo Piazza
  • Denmark
      • Copenhagen, Denmark, 2100
        • Withdrawn
        • Rigshospitalet
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama Birmingham (UAB)
        • Principal Investigator:
          • Mustafa Ahmed
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Recruiting
        • Abrazo Heart Hospital
        • Principal Investigator:
          • Timothy Byrne, MD
        • Principal Investigator:
          • Merick Kirshner, MD
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • Scripps Memorial Hospital
        • Principal Investigator:
          • Matthew Price, MD
        • Principal Investigator:
          • Scott Brewster, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Contact:
          • Saibal Kar, MD
        • Principal Investigator:
          • Raj Makkar, MD
        • Principal Investigator:
          • Danny Ramzy, MD
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center
        • Principal Investigator:
          • Somjot Brar, MD
        • Principal Investigator:
          • Blanding Jones, MD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Hospital of the University of Southern California
        • Principal Investigator:
          • Vaughn Starnes, MD
        • Principal Investigator:
          • Ray Vern Matthews, MD
      • Los Angeles, California, United States, 90017
        • Recruiting
        • PIH Health Good Samaritan Hospital
        • Principal Investigator:
          • Steven Burstein
      • Mountain View, California, United States, 94040
        • Recruiting
        • El Camino
        • Principal Investigator:
          • Chad Rammohan, MD
      • San Francisco, California, United States, 94118-3100
        • Recruiting
        • Kaiser Permanente San Francisco Medical Center
        • Principal Investigator:
          • Andrew Rassi, MD
        • Principal Investigator:
          • Ahmad Sheikh, MD
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Hospital and Clinics
        • Principal Investigator:
          • David Lee, MD
        • Principal Investigator:
          • Jack Boyd, MD
      • Thousand Oaks, California, United States, 91360-1847
        • Recruiting
        • Los Robles Regional Medical Center
        • Principal Investigator:
          • Saibal Kar
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Talhat Azemi, MD
        • Principal Investigator:
          • Sabet Hashim
        • Principal Investigator:
          • Robert Hagberg
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale New Haven Hospital
        • Principal Investigator:
          • John K Forrest, MD
        • Principal Investigator:
          • Prashanth Vallabhajosyula, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Principal Investigator:
          • Ron Waksman, MD
        • Principal Investigator:
          • Christian Shults, MD
    • Florida
      • Atlantis, Florida, United States, 33462
        • Recruiting
        • JFK Medical Center
        • Principal Investigator:
          • Mark Rothenberg, MD
        • Principal Investigator:
          • Marcos Nores, MD
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant
        • Principal Investigator:
          • Lang L Lin, MD
        • Principal Investigator:
          • Joshua J Rovin, MD
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • HealthPark Medical Center
        • Principal Investigator:
          • Murali Muppala, MD
        • Principal Investigator:
          • Michael DeFrain, MD
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • North Florida Regional Medical Center
        • Principal Investigator:
          • Ilie Barb, MD
        • Principal Investigator:
          • Charles Klodell, MD
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center Jacksonville
        • Principal Investigator:
          • Ruby Satpahy
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Hiram Bezerra
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Atlanta Hospital
        • Principal Investigator:
          • Pradeep Yadav, MD
        • Principal Investigator:
          • Thourani Vinod, MD
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Adam Greenbaum
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Hussam Suradi, MD
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • Chris S Malaisrie, MD
        • Principal Investigator:
          • Charles Davidson, MD
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center
        • Principal Investigator:
          • Atul Chawla, MD
        • Principal Investigator:
          • Bart Jenson, MD
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • The University of Kansas Hospital
        • Principal Investigator:
          • Mark Wiley, MD
        • Principal Investigator:
          • Emmanuel Daon, MD
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Principal Investigator:
          • Mark M Vesely, MD
        • Principal Investigator:
          • Bradley Taylor, MD
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • The Johns Hopkins Hospital
        • Principal Investigator:
          • Jon Resar, MD
        • Principal Investigator:
          • James Gammie, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Pinak Bipin Shah, MD
        • Principal Investigator:
          • Mark Cunningham, MD
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Ignacio Inglessis, MD
        • Principal Investigator:
          • Serguei Melnitchouk, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Laham Roger
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System
        • Principal Investigator:
          • Stanley Chetcuti, MD
        • Principal Investigator:
          • Steven Bolling, MD
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension St. John Hospital
        • Principal Investigator:
          • Theodore Schreiber
        • Principal Investigator:
          • Sanjay Batra
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health Hospital
        • Principal Investigator:
          • William Merhi, MD
        • Principal Investigator:
          • Stephane Leung Wai Sang, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical Center Fairview
        • Principal Investigator:
          • Gregory Helmer
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott Northwestern Hospital
        • Principal Investigator:
          • Paul Sorajja
    • Missouri
      • Saint Louis, Missouri, United States, 63110-1003
        • Recruiting
        • Barnes-Jewish Hospital
        • Principal Investigator:
          • Alan Zajarias, MD
        • Principal Investigator:
          • Puja Kachroo, MD
    • Montana
      • Missoula, Montana, United States, 59802-4008
        • Recruiting
        • Providence St Patrick
        • Principal Investigator:
          • Daniel Spoon
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Memorial Hospital
        • Principal Investigator:
          • Philippe Genereux, MD
        • Principal Investigator:
          • John Brown, MD
      • Neptune, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore University Medical Center
        • Principal Investigator:
          • Matthew Saybolt
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • North Shore University Hospital
        • Principal Investigator:
          • Bruce Rutkin, MD
        • Principal Investigator:
          • Sheel Vatsia, MD
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Hospital - Long Island
        • Principal Investigator:
          • Richard Schwartz, MD
        • Principal Investigator:
          • Khaled Salhab, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
        • Principal Investigator:
          • Susheel Kodali, MD
        • Principal Investigator:
          • Isaac George, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Principal Investigator:
          • Matthew Williams, MD
        • Principal Investigator:
          • Cezar Staniloae, MD
      • New York, New York, United States, 10029
        • Recruiting
        • The Mount Sinai Hospital
        • Principal Investigator:
          • Samin Sharma, MD
        • Principal Investigator:
          • David Adams, MD
      • New York, New York, United States, 10467-2401
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Tadahisa Sugiura
      • Roslyn, New York, United States, 11576
        • Recruiting
        • Saint Francis Hospital
        • Principal Investigator:
          • George Petrossian, MD
        • Principal Investigator:
          • Newell Robinson, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • J. Kevin Harrison, MD
        • Principal Investigator:
          • Carmelo Milano, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219-2906
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Joseph Choo, MD
        • Principal Investigator:
          • Geoffrey Answini, MD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Principal Investigator:
          • Guilherme Attizzani, MD
        • Principal Investigator:
          • Alan Markowitz, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Principal Investigator:
          • Konstantinos Boudoulas, MD
        • Principal Investigator:
          • Bryan Whitson, MD
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Riverside Methodist Hospital
        • Principal Investigator:
          • Steven Yakubov, MD
        • Principal Investigator:
          • Steven Duff, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris Baptist Medical Center
        • Contact:
          • Jill Fife
        • Principal Investigator:
          • Jeffrey Sparling, MD
        • Principal Investigator:
          • Craig Elkins, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Firas Zahr, MD
        • Principal Investigator:
          • Howard Song, MD
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Ethan Korngold, MD
        • Principal Investigator:
          • Eric Kirker, MD
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • UPMC Pinnacle Harrisburg Campus
        • Principal Investigator:
          • Hemal Gada, MD
        • Principal Investigator:
          • Mubashir Mumtaz, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center UPMC Presbyterian
        • Principal Investigator:
          • Ibrahim Sultan, MD
        • Principal Investigator:
          • Conrad Smith, MD
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Principal Investigator:
          • Basel Ramlawi, MD
        • Principal Investigator:
          • Scott S Goldman, MD
        • Principal Investigator:
          • William W Gray, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Principal Investigator:
          • Ashish Shah, MD
        • Principal Investigator:
          • Colin Barker, MD
        • Principal Investigator:
          • Brian Lindman, MD
    • Texas
      • Austin, Texas, United States, 78756
        • Recruiting
        • Heart Hospital of Austin
        • Principal Investigator:
          • Juhana Karha, MD
        • Principal Investigator:
          • Faraz Kerendi, MD
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Health Presbyterian Hospital Dallas
        • Principal Investigator:
          • James Park
        • Principal Investigator:
          • Brandon Hill
      • Dallas, Texas, United States, 75246
        • Withdrawn
        • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Richard Smalling, MD
        • Principal Investigator:
          • Anthony Estrera, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Neal Kleiman, MD
        • Principal Investigator:
          • Michael Reardon, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
        • Principal Investigator:
          • Guilherme Silva, MD
        • Principal Investigator:
          • Joseph Coselli, MD
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White Health (The Heart Hospital Baylor Plano)
        • Principal Investigator:
          • Molly Szerlip
        • Principal Investigator:
          • Robert Smith
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Hospital
        • Principal Investigator:
          • Jorge Alvarez, MD
        • Principal Investigator:
          • Brent New, MD
    • Vermont
      • Burlington, Vermont, United States, 05401-1473
        • Recruiting
        • The University of Vermont Medical Center
        • Principal Investigator:
          • Harold Dauerman
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Principal Investigator:
          • Scott Lim, MD
        • Principal Investigator:
          • Leora Yarboro, MD
      • Fairfax, Virginia, United States, 22042
        • Recruiting
        • Inova Fairfax Hospital
        • Principal Investigator:
          • Shahram Yazdani, MD
        • Principal Investigator:
          • Eric Sarin, MD
      • Norfolk, Virginia, United States, 23507-1904
        • Recruiting
        • Sentara Norfolk General Hospital
        • Principal Investigator:
          • Matthew Summers, MD
      • Richmond, Virginia, United States, 23226
        • Withdrawn
        • Saint Mary's Hospital/Bon Secours
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Roanoke Memorial Hospital
        • Principal Investigator:
          • Jason Foerst, MD
      • Winchester, Virginia, United States, 22601
        • Active, not recruiting
        • Winchester Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • James McCabe
      • Seattle, Washington, United States, 98122
        • Withdrawn
        • The Swedish Medical Center Cherry Hill
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center & Children's Hospital
        • Principal Investigator:
          • Philip Huber, MD
        • Principal Investigator:
          • Matthew Forrester, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St. Luke's Medical Center
        • Principal Investigator:
          • Tanvir Bajwa, MD
        • Principal Investigator:
          • Eric Weiss, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Moderate to severe or severe symptomatic mitral regurgitation
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Cohort- 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
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement
Experimental: Mitral Annular Calcification -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
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Cohort
Time Frame: 1 year
all-cause mortality or heart failure hospitalization post-30 days or KCCQ improvement < 10 composite
1 year
MAC Cohort
Time Frame: 1 year
all-cause mortality
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days or hospital discharge (whichever is later)
Change in New York Heart Association Class
Time Frame: 30 days
change in NYHA Class
30 days
Quality of Life Improvement
Time Frame: 30 days (SF-12) and 3 months (KCCQ)
measured by SF-12 and KCCQ
30 days (SF-12) and 3 months (KCCQ)
Echocardiographic assessments of degree mitral valve regurgitation
Time Frame: 1 year
measured by echocardiography
1 year
Cardiovascular hospitalizations
Time Frame: 1 year
cardiovascular hospitalizations
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: David Adams, MD, Icahn School of Medicine at Mount Sinai
  • Study Chair: Michael Mack, MD, Baylor Scott & White Hospital
  • Principal Investigator: Martin Leon, MD, New York Presbyterian Hospital/Columbia University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2017

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

September 30, 2035

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT17022TMV001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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