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

Status: Recruiting
Location: See all (62) 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: No
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
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
Kaiser Permanente San Francisco Medical Center
Recruiting
San Francisco
Stanford Hospital and Clinics
Recruiting
Stanford
Connecticut
Hartford Hospital
Recruiting
Hartford
Yale New Haven Hospital
Recruiting
New Haven
Washington, D.c.
MedStar Washington Hospital Center
Recruiting
Washington
Florida
JFK Medical Center
Recruiting
Atlantis
Morton Plant
Recruiting
Clearwater
HealthPark Medical Center
Recruiting
Fort Myers
North Florida Regional Medical Center
Recruiting
Gainesville
Georgia
Piedmont Atlanta Hospital
Recruiting
Atlanta
Iowa
Mercy Medical Center
Recruiting
Des Moines
Illinois
Northwestern Memorial Hospital
Recruiting
Chicago
Kansas
The University of Kansas Hospital
Recruiting
Kansas City
Massachusetts
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
Spectrum Health Hospital
Recruiting
Grand Rapids
Missouri
Barnes-Jewish Hospital
Recruiting
Saint Louis
North Carolina
Duke University Medical Center
Recruiting
Durham
New Jersey
Morristown Memorial Hospital
Recruiting
Morristown
New York
North Shore University Hospital
Recruiting
Manhasset
NYU Langone Hospital - Long Island
Recruiting
Mineola
Columbia University Medical Center/NYPH
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
University of Pittsburgh Medical Center 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
Active, not 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
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
Winchester Medical Center
Active, not recruiting
Winchester
Washington
The Swedish Medical Center Cherry Hill
Withdrawn
Seattle
Providence Sacred Heart Medical Center & Children's Hospital
Recruiting
Spokane
Wisconsin
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
Other Locations
Canada
Montreal Heart Insitute
Recruiting
Montreal
St. Michael's Hospital
Recruiting
Toronto
Sunnybrook Health Sciences Centre
Recruiting
Toronto
Denmark
Rigshospitalet
Withdrawn
Copenhagen
Contact Information
Primary
Laura O'Brien
rs.tmvrpivotaltrial@medtronic.com
7635289970
Time Frame
Start Date: October 23, 2017
Estimated Completion Date: October 2028
Participants
Target number of participants: 1350
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
James J Gammie, Joshua J Rovin, Vic Melkian, Jospeh Newton, Bart Jenson, Guilherme Silva, Ashish Shah, Anthony Estrera, Timothy Byrne, Sabet Hashim, Stanley Chetcuti, James Gammie, Charles Klodell, Eric Lehr, Brian Hummel, Scott S Goldman, Talhat Azemi, Atul Chawla, Cezar Staniloae, Kashish Goel, Merick Kirshner, Danny Ramzy, Sameer Gafoor, Daniel Watson, Arnar Geirsson, Paul Mahoney, William W Gray, Ilie Barb, Mubashir Mumtaz, Pradeep Yadav, Omar Ali, Andrew Rassi, Blanding Jones, Steven Yakubov, Ron Waksman, Robert Hagberg, Philippe Genereux, Steven Bolling, Tsuyoshi Kaneko, Michael DeFrain, Khaled Salhab, William Fearon, Faraz Kerendi, Hersh Maniar, Ethan Korngold, Jacob Mishell, Samin Sharma, Joseph Choo, John K Forrest, Shahram Yazdani, Charles Davidson, Eric Kirker, Steven Duff, Susheel Kodali, Richard Smalling, William Merhi, Alan Zajarias, Mark Rothenberg, Emmanuel Daon, Sheel Vatsia, Alan Markowitz, Murali Muppala, Colin Barker, Ibrahim Sultan, Michael Siegenthaler, James Kauten, Neal Kleiman, Jeffrey Sparling, Basel Ramlawi, Martin Leon, Serguei Melnitchouk, Leora Yarboro, Puja Kachroo, Newell Robinson, Philip Huber, Pinak Bipin Shah, Michael Reardon, Vaughn Starnes, Albert Henry, J. Kevin Harrison, David Lee, Firas Zahr, Thomas Gleason, Mark Wiley, Carmelo Milano, Juhana Karha, Saibal Kar, Eric Weiss, Joseph Woo, Konstantinos Boudoulas, Ahmad Sheikh, Barry Love, David Lim, Ray Vern Matthews, Rick Esposito, Eric Sarin, Richard Schwartz, Hemal Gada, Matthew Forrester, Joseph Coselli, Ravi Vallabhan, Lang Lin, Joshua Rovin, Isaac George, John Brown, Christian Shults, George Petrossian, Clayton Kaiser, Mario Castillo-Sang, Mark Bladergroen, Patrick McCarthy, Bruce Rutkin, Somjot Brar, Brian Lindman, Matthew Price, Marcos Nores, Daniel O'Hair, Bradley Taylor, John Heiser, Jack Boyd, James Garrison, Mark M Vesely, Scott Brewster, Tuyen Nguyen, Matthew Williams, Gideon Cohen, Talhat Muppala, Conrad Smith, Chris S Malaisrie, Guilherme Attizzani, Ignacio Inglessis, Howard Song, Brent New, Neil Fam, Andrew Czarnecki, Craig Elkins, Jon Resar, Mandal K Kaushik, Mark Peterson, David Adams, Christopher Meduri, Tanvir Bajwa, Anita Asgar, Bryan Whitson, Peter Skov Olsen, Lars Sondergaard, Raj Makkar, G. Chad Hughes, Scott Lim, Jorge Alvarez, Geoffrey Answini
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular

This content was sourced from clinicaltrials.gov

Similar Clinical Trials