Optimize PRO Transcatheter Aortic Valve Replacement Post Market Study
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an optimized TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices. The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: No
View:
• Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations;
• Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
• Subject and the treating physician agree that the subject will return for all required post procedure follow-up visits;
• Anatomically suitable for transfemoral TAVR with the Medtronic TAVR system;
• Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.
Locations
United States
Alabama
University of Alabama at Birmingham Hospital
Recruiting
Birmingham
California
California Pacific Medical Center - Sutter Health
Active, not recruiting
San Francisco
Connecticut
Hartford Hospital
Active, not recruiting
Hartford
Yale New Haven Hospital
Active, not recruiting
New Haven
St. Vincent's Hospital / Cardiology Associates of Fairfield County, P.C.
Recruiting
Norwalk
Florida
Morton Plant Hospital
Recruiting
Clearwater
Georgia
Emory University Hospital
Recruiting
Atlanta
Iowa
Mercy Medical Center
Withdrawn
Des Moines
Illinois
St. John's Hospital/Prarie Education and Research Cooperative
Active, not recruiting
Springfield
Maryland
Medstar Union Memorial Hospital
Active, not recruiting
Baltimore
Michigan
University of Michigan
Recruiting
Ann Arbor
Ascension St. John Hospital
Active, not recruiting
Detroit
Spectrum Health
Active, not recruiting
Grand Rapids
Minnesota
Abbott Northwestern Hospital (Minneapolis Heart)
Recruiting
Minneapolis
Montana
Providence St. Patrick Hospital
Active, not recruiting
Missoula
Nebraska
University of Nebraska Medical Center
Active, not recruiting
Omaha
New Jersey
Jersey Shore University Medical Center
Active, not recruiting
Neptune
The Valley Hospital
Active, not recruiting
Ridgewood
New York
Buffalo General Medical Center
Active, not recruiting
Buffalo
New York Presbyterian - Columbia University Medical Center
Active, not recruiting
New York
NYU Langone Medical Center
Withdrawn
New York
The Mount Sinai Hospital
Active, not recruiting
New York
Vassar Brother's Medical Center
Active, not recruiting
Poughkeepsie
St. Francis Hospital
Active, not recruiting
Roslyn
Stony Brook University Hospital
Active, not recruiting
Stony Brook
Ohio
Ohio Health Research Institute
Recruiting
Columbus
Kettering Medical Center
Active, not recruiting
Kettering
Pennsylvania
Lehigh Valley Hospital - Cedar Crest
Active, not recruiting
Allentown
UPMC Pinnacle Harrisburg
Recruiting
Harrisburg
Allegheny General Hospital
Recruiting
Pittsburgh
UPMC Presbyterian
Active, not recruiting
Pittsburgh
York Hospital
Active, not recruiting
York
Texas
HCA Houston Healthcare Medical Center
Withdrawn
Houston
Houston Methodist Hospital
Active, not recruiting
Houston
The Heart Hospital - Baylor Plano
Active, not recruiting
Plano
Utah
Dixie Regional Medical Center Intermountain
Active, not recruiting
Saint George
Virginia
Sentara Norfolk General Hospital
Active, not recruiting
Norfolk
Wisconsin
Aurora Saint Luke's Medical Center
Active, not recruiting
Milwaukee
West Virginia
Charleston Medical Center
Active, not recruiting
Charleston
Other Locations
Australia
The Prince Charles Hospital
Recruiting
Chermside West
Monash Hospital
Recruiting
Clayton
Austin Hospital
Recruiting
Heidelberg
Fiona Stanley Hospital
Recruiting
Murdoch
Saint Vincents Hospital Sydney
Recruiting
Sydney
Belgium
ZNA Middelheim
Recruiting
Antwerpen
St Jan Hospital
Recruiting
Brugge
Canada
Laval University Institute of Cardiology and Respirology of Quebec
Active, not recruiting
Québec
Sunnybrook Health Sciences Centre
Active, not recruiting
Toronto
France
Hôpitaux Universitaires - Hôpital Henri Mondor
Recruiting
Créteil
Hôpital Haut-Lévêque - CHU de Bordeaux
Recruiting
Pessac
Germany
Universitätsklinikum Ulm
Recruiting
Ulm
Ireland
Mater Private Hospital
Recruiting
Dublin
Galway University Hospitals - University Hospital Galway (UHG)
Recruiting
Galway
Israel
Shaare Zedek Medical Center
Recruiting
Jerusalem
Italy
Fondazione Poliambulanza
Recruiting
Brescia
Fondazione Policlinico Universitario Agostino Gemelli
Recruiting
Roma
Spain
Hospital Universitario Central de Asturas
Recruiting
Oviedo
Sweden
Akademiska Sjukhuset
Recruiting
Uppsala
United Kingdom
Royal Victoria Hospital - Belfast Health and Social Care Trust
Recruiting
Belfast
Manchester Royal Infirmary
Recruiting
Manchester
Contact Information
Primary
Amy Corrigan
rs.optimizepro@medtronic.com
763-514-4000
Backup
Linda Emterby
rs.optimizeproemea@medtronic.com
31(0)46725511242
Time Frame
Start Date: September 16, 2019
Estimated Completion Date: April 2025
Participants
Target number of participants: 800
Treatments
Primary Cohort
Authors
Sean Wilson, Bart Jenson, Matthew Saybolt, Danny Dvir, Thomas Davis, Robert Pyo, Talhat Azemi, Mark Burlingame, Aravinda Nanjundappa, Srinivasa Potluri, Cezar Staniloae, Pranav Loyalka, Anelechi Anyanwu, Paul Mahoney, Kendra Grubb, Joseph Newton, David Muller, Steven Yakubov, James Harvey, Robert Hagberg, Vijay Iyer, Tamim Nazif, Abeel Mangi, David McAllister, Thomas Bilfinger, Samin Sharma, John Forrest, Christian Spies, Brian Bethea, Daniel Spoon, Brian Schwartz, William Merhi, Matias Yudi, Ibrahim Sultan, Neal Kleiman, Robert Jumper, Ramzi Khalil, Newell Robinson, Nainesh Patel, James Maddux, Andrew Goldsweig, Timothy Misselbeck, Blake Gardner, Mustafa Ahmed, Hemal Gada, Jeffrey Christy, Nilesh Goswami, Katherine Harrington, Lang Lin, Joshua Rovin, George Petrossian, Adam Greenbaum, John Heiser, Mariano Brizzio, Zubair Jafar, John Wong, Prof. Cesar Moris de la Tassa, Jan van der Heyden, Mathew Williams, Prof. Thomas Modine, Colum Owens, Douglas Fraser, Michael Deeb, Teiger Emmanuel, Gerald Yong, Sanjay Batra, Stan Chetcuti, Dale Murdoch, Diego Maffeo, Prof. Mark Spence, Robert Gooley, Prof. Wolfgang Rottbauer, Josep Rodes-Cabau, Carlo Trani, Tanvir Bajwa, Paul Sorajja, Prof. Stefan James, Sam Radhakrishnan, Stefan Verheye, Darren Mylotte, David Lorenz
Related Therapeutic Areas
Sponsors
Leads: Medtronic Cardiovascular