Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO Trial
Status: Recruiting
Location: See all (85) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama Birmingham (UAB)
RECRUITING
Birmingham
Arizona
Abrazo Heart Hospital
RECRUITING
Phoenix
California
Scripps Memorial Hospital
RECRUITING
La Jolla
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Keck Hospital of the University of Southern California
RECRUITING
Los Angeles
PIH Health Good Samaritan Hospital
RECRUITING
Los Angeles
El Camino
RECRUITING
Mountain View
Kaiser Permanente San Francisco Medical Center
RECRUITING
San Francisco
Stanford Hospital and Clinics
RECRUITING
Stanford
Los Robles Regional Medical Center
RECRUITING
Thousand Oaks
Connecticut
Hartford Hospital
RECRUITING
Hartford
Yale New Haven Hospital
RECRUITING
New Haven
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
JFK Medical Center
RECRUITING
Atlantis
Morton Plant
RECRUITING
Clearwater
HealthPark Medical Center
ACTIVE_NOT_RECRUITING
Fort Myers
North Florida Regional Medical Center
RECRUITING
Gainesville
Baptist Medical Center Jacksonville
RECRUITING
Jacksonville
University of South Florida
RECRUITING
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Piedmont Atlanta Hospital
RECRUITING
Atlanta
Iowa
Mercy Medical Center
RECRUITING
Des Moines
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
Kansas
The University of Kansas Hospital
RECRUITING
Kansas City
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
The Johns Hopkins Hospital
RECRUITING
Baltimore
University of Maryland Medical Center
RECRUITING
Baltimore
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Henry Ford Saint John Hospital
RECRUITING
Detroit
Corewell Health
RECRUITING
Grand Rapids
Minnesota
Abbott Northwestern Hospital
RECRUITING
Minneapolis
M Health Fairview University of Minnesota Medical Center - East Bank
RECRUITING
Minneapolis
Missouri
Barnes-Jewish Hospital
RECRUITING
St Louis
Montana
Providence St Patrick
RECRUITING
Missoula
North Carolina
Duke University Medical Center
RECRUITING
Durham
New Jersey
Morristown Medical Center
RECRUITING
Morristown
Jersey Shore University Medical Center
RECRUITING
Neptune City
New York
North Shore University Hospital
RECRUITING
Manhasset
NYU Langone Hospital - Long Island
ACTIVE_NOT_RECRUITING
Mineola
Montefiore Medical Center
RECRUITING
New York
New York-Presbyterian Hospital Columbia University Medical Center
RECRUITING
New York
NYU Langone Medical Center
RECRUITING
New York
The Mount Sinai Hospital
RECRUITING
New York
Saint Francis Hospital
RECRUITING
Roslyn
Ohio
The Christ Hospital
RECRUITING
Cincinnati
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
OhioHealth Riverside Methodist Hospital
RECRUITING
Columbus
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Oklahoma
INTEGRIS Baptist Medical Center
RECRUITING
Oklahoma City
Oregon
Oregon Health and Science University
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
UPMC Pinnacle Harrisburg Campus
RECRUITING
Harrisburg
UPMC Presbyterian
RECRUITING
Pittsburgh
Lankenau Medical Center
RECRUITING
Wynnewood
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Heart Hospital of Austin
RECRUITING
Austin
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
WITHDRAWN
Dallas
Texas Health Presbyterian Hospital Dallas
RECRUITING
Dallas
CHI Saint Luke's Health-Baylor Saint Luke's Medical Center
RECRUITING
Houston
Houston Methodist Hospital
RECRUITING
Houston
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Baylor Scott & White Health (The Heart Hospital Baylor Plano)
RECRUITING
Plano
Methodist Hospital
RECRUITING
San Antonio
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Inova Fairfax Hospital
RECRUITING
Fairfax
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Saint Mary's Hospital/Bon Secours
WITHDRAWN
Richmond
Carilion Roanoke Memorial Hospital
RECRUITING
Roanoke
Winchester Medical Center
ACTIVE_NOT_RECRUITING
Winchester
Vermont
The University of Vermont Medical Center
RECRUITING
Burlington
Washington
The Swedish Medical Center Cherry Hill
WITHDRAWN
Seattle
University of Washington
RECRUITING
Seattle
Providence Sacred Heart Medical Center & Children's Hospital
RECRUITING
Spokane
Wisconsin
Aurora St. Luke's Medical Center
RECRUITING
Milwaukee
Other Locations
Canada
Glen Royal Victoria Hospital
RECRUITING
Montreal
Montreal Heart Insitute
RECRUITING
Montreal
Royal Columbian Hospital
RECRUITING
New Westminster
St. Michael's Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
St. Paul's Hospital
RECRUITING
Vancouver
Denmark
Rigshospitalet
WITHDRAWN
Copenhagen
Contact Information
Primary
Megan Wilder Fredrickson
rs.tmvrpivotaltrial@medtronic.com
612-469-1749
Time Frame
Start Date: 2017-10-23
Estimated Completion Date: 2036-09-30
Participants
Target number of participants: 1056
Treatments
Experimental: Primary Cohort- TMVR
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Experimental: Mitral Annular Calcification -TMVR
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Authors
Richard Schwartz, Bart Jenson, Guilherme Attizzani, Eric Lehr, Brian Hummel, Atul Chawla, Kashish Goel, Danny Ramzy, Sameer Gafoor, Daniel Watson, Paul Mahoney, Mubashir Mumtaz, Bryan Whitson, Tsuyoshi Kaneko, Tanvir Bajwa, Khaled Salhab, William Fearon, Faraz Kerendi, Hersh Maniar, Ethan Korngold, Howard Song, Jacob Mishell, Joseph Choo, Shahram Yazdani, Eric Kirker, William Merhi, Alan Zajarias, Emmanuel Daon, Alan Markowitz, Murali Muppala, Michael Siegenthaler, James Kauten, Martin Leon, Christopher Meduri, David Adams, Vaughn Starnes, Albert Henry, Firas Zahr, Mark Wiley, Juhana Karha, Saibal Kar, James Garrison, Konstantinos Boudoulas, Barry Love, David Lim, Ray Matthews, Rick Esposito, Eric Sarin, Hemal Gada, Ravi Vallabhan, Lang Lin, Joshua Rovin, Clayton Kaiser, Mario Castillo-Sang, Mark Bladergroen, Patrick McCarthy, Brian Lindman, John Heiser, Thomas Gleason, Omar Ali, Arnar Geirsson, Eric Weiss, Daniel O'Hair, Lars Sondergaard, Peter Skov Olsen
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular