Evolut™ EXPAND TAVR II Pivotal Trial
April 4, 2024 updated by: Medtronic Cardiovascular
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, symptomatic AS.
Study Overview
Status
Recruiting
Detailed Description
Multi-center, international, prospective, randomized study.
Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.
Study Type
Interventional
Enrollment (Estimated)
650
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
- Name: Hang Nguyen
- Phone Number: +1765262832
- Email: hang.t.nguyen@medtronic.com
Study Contact Backup
- Name: Hang Nguyen
- Email: rs.expandii@medtronic.com
Study Locations
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Murdoch, Australia, 6150
- Recruiting
- Fiona Stanley Hospital
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Contact:
- Gerald Yong, MBBS
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Contact:
- James Lambert, MBBS
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Victoria
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Melbourne, Victoria, Australia, 3004
- Recruiting
- The Alfred Hospital
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Contact:
- Tony Walton, MD
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Contact:
- James Hare, MD
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Wien, Austria, 1030
- Recruiting
- Allgemeines Krankenhaus - Universitätskliniken Wien
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Contact:
- Christian Hengstenberg, M.D.
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Contact:
- Raphael Rosenhek, M.D.
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Liège, Belgium, 4000
- Recruiting
- CHU de Liege- Hopital du Sart Tilman
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Contact:
- Patrizio Lancellotti, M.D.
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Contact:
- Raluca Dulgheru, M.D.
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Halifax, Canada, B3H 3A7
- Recruiting
- Queen Elizabeth II Health Sciences Centre
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Contact:
- Osama Elkhateeb, MD
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Contact:
- Daniel Belliveau, MD
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Ontario
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London, Ontario, Canada, N6A 5A5
- Recruiting
- London Health Sciences Centre - University Campus
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Contact:
- Rodrigo Bagur, MD
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Contact:
- Michael Chu, MD
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
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Contact:
- Sam Radhakrishnan, M.D.
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Contact:
- Idan Roifman, M.D
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Quebec
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Montréal, Quebec, Canada, H1T1C8
- Recruiting
- Montreal Heart Hospital
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Contact:
- Walid Ben Ali, MD
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Contact:
- Anita Asgar, MD
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Quebec City, Quebec, Canada, G1V 4G5
- Recruiting
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
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Contact:
- Josep Rodes-Cabau, MD
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Contact:
- Mathieu Bernier, MD
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Copenhagen, Denmark
- Recruiting
- Rigshospitalet
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Contact:
- Ole de Backer, M.D.
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Contact:
- Jacob Moeller, M.D.
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Brest, France, 29609
- Recruiting
- CHRU Brest - Hôpital de la Cavale Blanche
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Contact:
- Martine Gilard, MD
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Contact:
- Romain Didier, MD
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Clermont-Ferrand, France, 63 000
- Recruiting
- Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
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Contact:
- Nicolas Combaret, M.D.
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Contact:
- Guilleaume Clerfond, M.D.
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Marseille, France
- Recruiting
- Hôpital de la Timone
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Contact:
- Thomas Cuisset, M.D.
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Contact:
- Gilbert Habib, M.D.
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Paris, France, 75015
- Recruiting
- Hôpital Européen Georges Pompidou
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Contact:
- Nicole Karam, MD
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Contact:
- Paul Achouh, MD
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Paris, France, 75014
- Recruiting
- Institut Mutualiste Montsouris
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Contact:
- Christophe Caussin, MD
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Contact:
- Jean-Luc Monin, MD
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Toulouse Cedex, France, 3,31076
- Recruiting
- Clinique Pasteur
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Contact:
- Nicolas Nicolas, MD
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Contact:
- Laurent Lepage, MD
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Bad Krozingen, Germany, 79189
- Recruiting
- Universitäts-Herzzentrum Freiburg - Bad Krozingen
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Contact:
- Jurgen Rothe, MD
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Contact:
- Wolgang Zeh, MD
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Bonn, Germany, 53217
- Recruiting
- Universitätsklinikum Bonn
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Contact:
- Georg Nickenig, MD
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Contact:
- Sebastian Zimmer, MD
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Dortmund, Germany, 44137
- Recruiting
- Kath Saint Johannes-Gesellschaft Dortmund gGmbH Saint Johannes-Hospital Dortmund
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Contact:
- Helge Mollmann, MD
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Contact:
- Johannes Blumenstein, MD
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Leipzig, Germany, 04289
- Recruiting
- Herzzentrum Leipzig GmbH
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Contact:
- Mohamed Abdel Wahab, MD
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Mainz, Germany, 55131
- Recruiting
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Contact:
- Stephan von Bardeleben, MD
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Contact:
- Hendrik Treede, MD
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München, Germany, 15, 81377
- Recruiting
- Klinikum der Universität München - Campus Großhadern
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Contact:
- Steffen Massberg, MD
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Contact:
- Daniel Thomas Braun, MD
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Galway, Ireland, H91 YR71
- Recruiting
- Galway University Hospitals - University Hospital Galway (UHG)
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Contact:
- Darren Mylotte, MD
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Contact:
- Yvonne Smyth, MD
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Jerusalem, Israel, 9103102
- Recruiting
- Shaare Zedek Medical Center
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Contact:
- Danny Dvir, M.D.
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Contact:
- Tal Hassin
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Petah Tikva, Israel, 49100
- Recruiting
- Rabin Medical Center- Beilinson Hospital
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Contact:
- Ran Kornowski, M.D.
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Contact:
- Yaron Shapira, M.D.
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Catania, Italy, 95123
- Recruiting
- Presidio Ospedaliero Gaspare Rodolico
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Contact:
- Corrado Tamburino, MD
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Contact:
- Piera Capranzano, MD
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Milano, Italy, 20132
- Recruiting
- Ospedale San Raffaele - Milano
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Contact:
- Matteo Montorfano, MD
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Contact:
- Silvia Ajello, MD
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San Donato Milanese, Italy, 20097
- Recruiting
- IRCCS Policlinico San Donato
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Contact:
- Nedy Brambilla, M.D.
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Contact:
- Marta Barletta, M.D.
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Osaka, Japan, 565-0871
- Recruiting
- Osaka University Hospital
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Contact:
- Shigeru Miyagawa, M.D.
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Contact:
- Yasushi Sakata, M.D.
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Osaka, Japan, 543-0035
- Recruiting
- Osaka Police Hospital
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Contact:
- Yoshiki Sawa, MD
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Contact:
- Yoshiharu Higuchi, MD
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Kamakura
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Kanagawa, Kamakura, Japan, 247-8533
- Recruiting
- Shonan Kamakura General Hospital
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Contact:
- Shigeru Saito, MD
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Contact:
- Tomoki Ochiai, MD
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Kanagawa
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Isehara, Kanagawa, Japan, 259-1193
- Recruiting
- Tokai University Hospital
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Contact:
- Yohei Ohno, MD
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Contact:
- Yasunori Cho, MD
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Kawasaki, Kanagawa, Japan, 212-0014
- Recruiting
- Kawasaki Saiwai Hospital
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Contact:
- Tetsuya Tobaru
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Contact:
- Shuichiro Takanashi
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Eindhoven, Netherlands
- Recruiting
- Catharina Ziekenhuis
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Contact:
- Pim Tonino
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Contact:
- Kayan Lam
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Groningen, Netherlands, 9713 GZ
- Recruiting
- Universitair Medisch Centrum Groningen
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Contact:
- Joanna Wykrzykowska, MD
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Contact:
- Adriaan Voors, MD
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Nieuwegein, Netherlands, 3435
- Recruiting
- St Antonius Ziekenhuis
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Contact:
- Leonardus Timmers, M.D.
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Contact:
- Martin Swaans, M.D.
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Barcelona, Spain, 08036
- Recruiting
- Hospital Universitari Clínic de Barcelona
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Contact:
- Ander Regueiro, M.D.
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Contact:
- Barbara Vidal i Hagemeijer, M.D.
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Madrid, Spain, 28034
- Recruiting
- Hospital Universitario Ramon Y Cajal
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Contact:
- Angel Sanchez Recalde, M.D.
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Contact:
- Jose Zamorano, M.D.
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Salamanca, Spain, 37007
- Recruiting
- Complejo Asistencial Universitario de Salamanca
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Contact:
- Ignacio Cruz, M.D.
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Contact:
- Beatriz Tapia, M.D.
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Valladolid, Spain, 47006
- Recruiting
- Hospital Clínico Universitario de Valladolid
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Contact:
- Ignacio Amat, M.D.
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Contact:
- Javier Lopez Diaz, M.D.
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Lund, Sweden, 22185
- Recruiting
- Skanes universitetssjukhus
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Contact:
- Mathias Gotberg, MD
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Contact:
- Patrik Gilje, MD
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Bern, Switzerland, 3010
- Recruiting
- Inselspital - Universitätsspital Bern
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Contact:
- Thomas Pilgrim, MD
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Contact:
- Michael Schmid, MD
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London, United Kingdom, EC1A 7BE
- Recruiting
- Saint Bartholomew's Hospital
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Contact:
- Andreas Brombach, MD
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Oxford
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Headington, Oxford, United Kingdom, OX3 9DU
- Recruiting
- Oxford University Hospitals NHS Trust - John Radcliffe Hospital
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Contact:
- Raj Kharbanda, M.D.
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Contact:
- Jim Newton, M.D.
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U.k.
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Belfast, U.k., United Kingdom, BT9 7AB
- Recruiting
- Royal Victoria Hospital - Belfast Health and Social Care Trust
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Contact:
- Ganesh Manoharan, M.D.
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Contact:
- Reuben Jeganathan, M.D.
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham (UAB) Hospital
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Contact:
- Mustafa Ahmed, M.D.
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Contact:
- Dylan Addis, M.D.
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Arizona
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Phoenix, Arizona, United States, 85016
- Recruiting
- Abrazo Arizone Heart Hospital
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Contact:
- Tim Byrne, M.D.
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Contact:
- Merick Kirshner, M.D.
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Scottsdale, Arizona, United States, 85260
- Recruiting
- HonorHealth Scottsdale Shea Medical Center
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Contact:
- David Rizik, M.D.
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California
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Thousand Oaks, California, United States, 91360
- Recruiting
- Los Robles Hospital & Medical Center
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Contact:
- Gregory Fontana, M.D.
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Contact:
- David Aliabadi, M.D.
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Hospital
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Contact:
- John C Messenger, M.D.
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Contact:
- Joseph Cleveland, M.D.
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Connecticut
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Bridgeport, Connecticut, United States, 06606-4201
- Recruiting
- Saint Vincents Medical Center
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Contact:
- David Lorenz, M.D.
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Contact:
- Robert Jumper, M.D.
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Hartford, Connecticut, United States, 06106
- Recruiting
- Hartford Hospital
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Contact:
- Immad Sadiq
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Contact:
- Eric Oligino, M.D.
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Recruiting
- MedStar Washington Hospital Center
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Contact:
- Ron Waksman, MD
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Contact:
- Diego Medvedofsky, MD
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Florida
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Clearwater, Florida, United States, 33756
- Recruiting
- Morton Plant Hospital
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Contact:
- Lang Lin, M.D.
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Contact:
- Joshua Rovin, M.D.
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Gainesville, Florida, United States, 32608
- Recruiting
- University of Florida
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Contact:
- R. David Anderson, M.D.
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Contact:
- Thomas Beaver, M.D.
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Jacksonville, Florida, United States, 32204
- Recruiting
- Saint Vincent's Medical Center Riverside
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Contact:
- Samer Garas, M.D.
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Contact:
- Nima Taghipour, M.D
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Orlando, Florida, United States, 32806
- Recruiting
- Orlando Health
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Contact:
- Deepak Vivek, MD
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Contact:
- Jonathan Rodriguez-Ortiz, MD
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Tallahassee, Florida, United States, 32308-5054
- Recruiting
- Tallahassee Memorial Hospital
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Contact:
- Thomas Noel, M.D.
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Contact:
- Gregory Hartlage, M.D.
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Tampa, Florida, United States, 33620
- Recruiting
- Tampa General Hospital
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Contact:
- Hiriam Bezerra, M.D.
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Contact:
- Lucian Lozonschi, M.D.
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Kentucky
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Louisville, Kentucky, United States, 40202
- Recruiting
- Jewish Hospital
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Contact:
- Narish Solankhi, M.D.
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Contact:
- Mark Slaughter, M.D
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Louisiana
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Houma, Louisiana, United States, 70360
- Recruiting
- Terrebonne General Medical Center
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Contact:
- Peter Fail
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Contact:
- Darrell Solet
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- The Johns Hopkins Hospital
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Contact:
- John Resar, MD
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Contact:
- Nisha Gilotra, MD
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
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Contact:
- Marie-France Poulin, M.D.
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Contact:
- Louis Chu, M.D.
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Boston, Massachusetts, United States, 02111
- Recruiting
- Tufts Medical Center
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Contact:
- Charles Resar, MD
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Contact:
- Benjamin Wessler, MD
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Springfield, Massachusetts, United States, 01199
- Recruiting
- Baystate Medical Center
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Contact:
- Ashequl Islam, M.D.
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Contact:
- Anthony Rousou, M.D.
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Michigan
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Ann Arbor, Michigan, United States, 48109-1274
- Recruiting
- University of Michigan Health System - University Hospital
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Contact:
- Stanley Chetcuti, MD
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Contact:
- Andrew Harris, MD
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Detroit, Michigan, United States, 48236
- Recruiting
- Ascension Saint John Hospital
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Contact:
- Thomas Davis, M.D.
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Contact:
- Sanjay Batra, M.D.
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Grand Rapids, Michigan, United States, 49503
- Recruiting
- Spectrum Health
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Contact:
- William Mehri, M.D.
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Contact:
- John Heiser, M.D.
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Minnesota
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Minneapolis, Minnesota, United States, 55407
- Recruiting
- Abbott Northwestern Hospital
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Contact:
- Paul Sorajja, M.D.
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Contact:
- Steven Bradley, M.D.
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Sorin Pislaru, MD
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Contact:
- Mackram Eleid, MD
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- SSM Health Saint Louis University Hospital
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Contact:
- Divya Verma, MD
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Contact:
- Steven Smart, MD
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New Hampshire
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Manchester, New Hampshire, United States, 03102
- Recruiting
- Catholic Medical Center
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Contact:
- Fahad Gilani
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Contact:
- Robert Capodilupo, MD
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New Jersey
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Browns Mills, New Jersey, United States, 08015
- Recruiting
- Deborah Heart and Lung Center
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Contact:
- Muhammad Raza, M.D.
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Contact:
- Kulpreet Barn, M.D.
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Englewood, New Jersey, United States, 076931
- Recruiting
- Englewood Hospital & Medical Center
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Contact:
- Ramin Hastings, MD
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Contact:
- Adam Arnofsky, MD
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New York
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Manhasset, New York, United States, 11030
- Recruiting
- Northwell Health
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Contact:
- Bruce Rutkin, M.D.
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Contact:
- Elena Koss, M.D.
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New York, New York, United States, 10029
- Recruiting
- The Mount Sinai Hospital
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Contact:
- Samin Sharma, MD
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Contact:
- Tara Naib
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North Carolina
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Asheville, North Carolina, United States, 28801
- Recruiting
- Mission Hospital
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Contact:
- Michael Chenier, M.D.
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Contact:
- Mark Groh, M.D.
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Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Heatlh Sciences
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Contact:
- David Zhao, M.D.
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Contact:
- Edward Kincaid, M.D.
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Ohio
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Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
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Contact:
- Rishi Puri, M.D.
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Contact:
- Serge Harb, M.D.
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Cleveland, Ohio, United States, 44106-1716
- Recruiting
- University Hospitals Cleveland Medical Center
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Contact:
- Guilherme Attizzani, MD
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Contact:
- Cristian Baeza, MD
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center
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Contact:
- Scott Lillt, M.D.
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Contact:
- Asvin Ganapathi, M.D.
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Kettering, Ohio, United States, 45429
- Recruiting
- Kettering Health Main Campus
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Contact:
- Brian Schwartz, M.D.
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Contact:
- Ammar Safar, M.D.
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Recruiting
- Integris Baptist Medical Center
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Contact:
- George Chrysant, M.D.
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Contact:
- Craig Elkins, M.D.
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University Hospital
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Contact:
- Harsh Golwala, M.D.
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Contact:
- Scott Chadderdon, M.D.
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Recruiting
- Lehigh Valley Hospital, Inc
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Contact:
- William Combs, M.D.
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Contact:
- Daniel Makowski, M.D.
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Harrisburg, Pennsylvania, United States, 17101
- Recruiting
- UPMC Pinnacle Harrisburg Campus
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Contact:
- Hemal Gada, M.D.
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Contact:
- Atizazul Hassan Mansoor, M.D.
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Hospital of the University of Pennsylvania
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Contact:
- Paul Fiorilli, M.D.
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Contact:
- Tiffany Chen, M.D.
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Recruiting
- Monument Health Rapid City Hospital
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Contact:
- Joseph Tuma, M.D.
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Contact:
- Rajesh Pradhan, M.D.
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- Recruiting
- Erlanger Medical Center
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Contact:
- Megan Coylewright, MD
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Contact:
- Patrick Stevens, MD
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Texas
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Dallas, Texas, United States, 75230
- Recruiting
- Medical City Dallas
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Contact:
- Bruce Bowers, M.D.
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Contact:
- Todd Dewey, M.D.
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Fort Worth, Texas, United States, 76104
- Recruiting
- Texas Health Harris Methodist Hospital Fort Worth
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Contact:
- Sukesh Sukesh Burjonroppa, M.D.
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Contact:
- Arun Padala, M.D.
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Houston, Texas, United States, 77030
- Recruiting
- Houston Methosidst Hospital
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Contact:
- Michael Reardon, MD
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Contact:
- Neal Kleiman, MD
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Utah
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Salt Lake City, Utah, United States, 84111
- Recruiting
- Intermountain Cardiovascular and Thoracic Surgery
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Contact:
- Blake Gardner, MD
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Contact:
- Jason Bowles, MD
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Vermont
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Burlington, Vermont, United States, 05401-1473
- Recruiting
- The University of Vermont
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Contact:
- Harold Dauerman, M.D.
-
Contact:
- Peter Van Buren, M.D.
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Virginia
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Roanoke, Virginia, United States, 24014
- Recruiting
- Carilion Roanoke Memorial Hospital
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Contact:
- Jason Forest, M.D.
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Contact:
- John Lystash, M.D.
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Washington
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Spokane, Washington, United States, 99204
- Recruiting
- Providence Sacred Heart Medical Center & Children's Hospital
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Contact:
- Brydan Curtis, M.D.
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Contact:
- Kavisha Singh, M.D.
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West Virginia
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Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University
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Contact:
- Ramesh Daggubati, MD
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Contact:
- Balla Sudarshan, MD
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- Recruiting
- Aurora Stint Lukes Medical Center
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Contact:
- Bajwa Tanvir, MD
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Contact:
- Jain Renuka, MD
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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
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Key Inclusion Criteria:
• Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the
ECL:
- AVA >1.0 cm² and < 1.5 cm² and
Max aortic velocity ≥ 3.0 m/sec and < 4.0 m/sec, OR mean aortic gradient ≥ 20.0 mmHg and < 40.0 mmHg,
• Symptoms of AS, defined as
- NYHA ≥ Class II, or
- Reduced functional capacity, defined as
- 6MWT < 300 meters, or
< 85% of age-sex predicted METs on exercise tolerance testing (ETT)
• Any of the following
- HF event or hospitalization for heart failure within 1 calendar year prior to consent
- NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml),
- Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
- Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or
- Any of the following by the qualifying TTE as assessed by the ECL:
- Global longitudinal strain ≤16% (absolute value)
- E/e' ≥ 14.0 (average of medial and lateral velocities), or
- Diastolic dysfunction ≥ Grade II
- LVEF < 60%
- Stroke Volume Index < 35 ml/m²
- Anatomically suitable for transfemoral RAVR using the Medtronic Evolut PRO+ or Evolut FX system
- The subject and the treating physician agree the subject will return for all required follow-up visits
Key Exclusion Criteria:
- Age < 65 years
- LVEF ≤ 20% by 2-D echo
- Class I indication for cardiac surgery
- Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm
- Not anatomically suitable for transfemoral TAVR with the trial device
- In need of and suitable for coronary revascularization per Heart Valve Team
- Documented history of cardiac amyloidosis
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy
|
Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).
|
|
No Intervention: Clinical site determined guideline-directed management and therapy (GDMT) alone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
Time Frame: 30 days
|
Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
|
30 days
|
|
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All-cause mortality
Time Frame: 2 years
|
2 years
|
|
Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)
Time Frame: 1 year
|
1 year
|
|
Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations
Time Frame: 2 years
|
2 years
|
|
Unplanned cardiovascular hospitalizations
Time Frame: 2 years
|
2 years
|
|
Days alive and free of unplanned cardiovascular hospitalizations
Time Frame: 2 years
|
2 years
|
|
Composite of all-cause mortality and heart failure hospitalizations or events.
Time Frame: 2 years
|
2 years
|
|
Heart failure hospitalizations or events.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul Sorajja, MD, Allina Health System
- Principal Investigator: Josep Rodes-Cabau, MD, Fondation IUCPQ
- Principal Investigator: Stephan Windecker, Prof., Inselspital, Universitätsspital Bern
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)
April 27, 2022
Primary Completion (Estimated)
February 1, 2026
Study Completion (Estimated)
December 1, 2034
Study Registration Dates
First Submitted
November 24, 2021
First Submitted That Met QC Criteria
November 24, 2021
First Posted (Actual)
December 8, 2021
Study Record Updates
Last Update Posted (Actual)
April 5, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D00411092
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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