Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation

Status: Recruiting
Location: See all (95) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Eighteen (18) years of age or older

• Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.

• Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).

• Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)

• Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip

• Mitral regurgitation (3+ to 4+) by echo

• Suitable valve and regurgitant jet morphology

• Elevated BNP > 150 pg/ml or corrected NT-pro BNP of > 600 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)

Locations
United States
Alabama
The University of Alabama at Birmingham
Recruiting
Birmingham
Arizona
Abrazo Arizona Heart Hospital
Recruiting
Phoenix
Arizona Cardiovascular Research Center
Recruiting
Phoenix
Banner University Medical Center
Recruiting
Phoenix
TMC Healthcare
Recruiting
Tucson
California
Cedars Sinai Medical Center
Recruiting
Los Angeles
PIH Health Good Samaritan Hospital
Recruiting
Los Angeles
St. Joseph Hospital
Recruiting
Orange
Sutter Medical Center-Sacramento
Recruiting
Sacramento
UC Davis Medical Center
Withdrawn
Sacramento
Scripps Memorial Hospital La Jolla
Recruiting
San Diego
Kaiser Permanente San Francisco
Recruiting
San Francisco
Sutter Bay Area
Recruiting
San Francisco
Stanford University
Recruiting
Stanford
Los Robles Hospital and Medical Center
Recruiting
Thousand Oaks
Colorado
University of Colorado Hospital
Recruiting
Aurora
Medical Center of the Rockies
Recruiting
Loveland
Washington, D.c.
Medstar Washington Hospital Center
Recruiting
Washington
Florida
The Cardiac and Vascular Institute Research Foundation
Recruiting
Gainesville
Mount Sinai
Recruiting
Miami Beach
AdventHealth Orlando
Active, not recruiting
Orlando
Cleveland Clinic Florida
Recruiting
Weston
Georgia
Emory University Hospital and Emory University Hospital Midtown
Recruiting
Atlanta
Piedmont Healthcare
Recruiting
Atlanta
Iowa
University of Iowa Hospitals & Clinics
Recruiting
Iowa City
Illinois
Northwestern University
Recruiting
Chicago
Advocate Health & Hospitals Corp/Edward Heart Hospital
Withdrawn
Naperville
Indiana
St. Vincent Heart Center
Recruiting
Indianapolis
Kansas
Cardiovascular Research Institute of Kansas
Withdrawn
Wichita
Louisiana
Oschner Medical Center
Recruiting
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Recruiting
Boston
Brigham and Woman's Hospital
Recruiting
Boston
Massachusetts General Hospital
Recruiting
Boston
Michigan
University of Michigan
Recruiting
Ann Arbor
Henry Ford Hospital
Recruiting
Detroit
Minnesota
Fairview Health Services
Recruiting
Maplewood
Mayo Clinic
Recruiting
Rochester
Missouri
St.Luke's Hospital of Kansas City
Recruiting
Kansas City
North Carolina
Atrium Health/Sanger Heart & Vascular Institute
Active, not recruiting
Charlotte
New Jersey
Morristown Medical Center
Recruiting
Morristown
Rutgers-RWJMS
Recruiting
New Brunswick
New York
Albany Medical College
Recruiting
Albany
Montefiore Medical Center
Recruiting
Bronx
State University of New York at Buffalo
Recruiting
Buffalo
NYU Winthrop Hospital
Recruiting
Mineola
Columbia University Medical Center/New York Presbyterian Hospital
Recruiting
New York
Lenox Hill Hospital and North Shore University
Recruiting
New York
NYU Langone Health
Recruiting
New York
Rochester General Hospital
Recruiting
Rochester
St. Francis Hospital
Recruiting
Roslyn
Ohio
The Christ Hospital
Recruiting
Cincinnati
Cleveland Clinic Foundation
Recruiting
Cleveland
OhioHealth Research Institute
Recruiting
Columbus
The Ohio State University Medical Center
Recruiting
Columbus
Oklahoma
Integris Health Baptist Medical Center
Recruiting
Oklahoma City
Oklahoma Cardiovascular
Recruiting
Oklahoma City
Oklahoma Heart Institute
Recruiting
Tulsa
Oregon
Oregon Health & Science University
Recruiting
Portland
Providence St. Vincent Medical Center
Recruiting
Portland
Pennsylvania
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
Recruiting
Wormleysburg
Lankenau Medical Center
Recruiting
Wynnewood
Tennessee
Centennial Medical Center
Recruiting
Nashville
Saint Thomas Heart at Saint Thomas West
Recruiting
Nashville
Vanderbilt University Medical Center
Recruiting
Nashville
Texas
Medical City Dallas
Withdrawn
Dallas
Baylor College of Medicine
Recruiting
Houston
HCA Houston Healthcare Medical Center
Recruiting
Houston
Houston Methodist Hospital
Recruiting
Houston
The University of Texas Health Science Center at Houston
Recruiting
Houston
The Heart Hospital Baylor Plano
Recruiting
Plano
Utah
Intermountain Medical Center
Recruiting
Salt Lake City
Virginia
University of Virginia
Recruiting
Charlottesville
Sentara Norfolk General Hospital
Recruiting
Norfolk
Chippenham Johnston & Willis Medical Center
Recruiting
Richmond
Washington
Swedish Medical Center
Recruiting
Seattle
University of Washington
Recruiting
Seattle
Wisconsin
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
Other Locations
Canada
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval
Recruiting
Québec
St. Michael's Hospital
Recruiting
Toronto
St. Pauls Hospital
Recruiting
Vancouver
Germany
Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum
Recruiting
Bad Oeynhausen
Herzzentrum Universitätsklinikum Koln
Recruiting
Cologne
Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden
Recruiting
Dresden
Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum
Recruiting
Essen
Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie
Recruiting
Gießen
Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie
Recruiting
Hamburg
Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie
Recruiting
Heidelberg
Herzzentrum Leipzig Universitätsklinik für Kardiologie
Recruiting
Leipzig
Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz
Recruiting
Mainz
Medizinische Klinik I LMU München Campus Grosshadern
Recruiting
München
Helios Klinikum Siegburg
Recruiting
Siegburg
ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II
Recruiting
Ulm
Switzerland
University Hospital Bern
Recruiting
Bern
Contact Information
Primary
Edwards TMTT Clinical Affairs
TMTT_Clinical@edwards.com
(949) 250-2500
Time Frame
Start Date: November 30, 2018
Estimated Completion Date: January 31, 2028
Participants
Target number of participants: 1275
Treatments
Experimental: Edwards PASCAL System - CLASP IID
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
Active Comparator: Abbott Mitraclip System - CLASP IID
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
Experimental: Edwards PASCAL System - CLASP IIF
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
Active Comparator: Abbott Mitraclip System - CLASP IIF
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
Experimental: Edwards PASCAL System - Single-Arm Registry
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.
Authors
David C Lui, Istik Ben-dor, Chandan Deveriddy, Scott Lily, Leonard Rodriguez, Kate Rajotte, C. Patrick Green, Anhil Narang, Vic Melikian, Prihi Mehla, Sayta Shreenivas, William O'Neill, George Gubernikoff, Selma Mohammed, Guilherme Silva, Aubrey Hall, Anthony Estrera, Devin Kehl, Richard Ericson, George Chrysant, Venkateshwar Polsani, Bassem M Chehab, Nader Makki, Phillip A Horwitz, Roshin Mathew, James McCabe, Eugene Pashkovetsky, Neil Gheewala, Hector Ventura, David Aliabadi, Jeremiah Depta, Abdul Hakeem, Timothy Byrne, Tomomi Oka, Robert Quaife, Gene Chang, Jean-Michel Paradis, Mark Reisman, Brett E Grizzell, Kellie Graham, Timothy George, Brian K Whisenant, Hassan Sayegh, Mustafa Toma, Gregory Franklin, Naveen Saha, Ramzi El Accaoui, Igor Palacios, Stanley Chetcuti, Rajeev Mohan, Kamal Khabbaz, Charles Klodell, Thomas Waggoner, Eric Lehr, Samuel Horr, Ming Zhang, Augustin Delago, Todd Dewey, Jon Blaschke, Robert Levitt, Rhonda Miyasaka, Scott Goldman, Erum Bajwa, Kimberly Staffey, Sunu Thomas, Amar Krishnaswamy, Stephen Bailey, Mudassar Ahmed, John Saxon, Kelly Chewning, Stephen Spindel, Brandon Jones, Cezar Staniloae, Mayra Guerrero, Nasir Sulemanjee, Serge Harb, Aman Ali, Tiberio Frisoli, Steven Voskanian, Pranav Loyalka, Vinayak Bapat, Thomas Zeyl, James B Hermiller, Kashish Goel, Merick Kirshner, Danny Ramzy, Ivy Ku, Thura Harfi, Sameer Gafoor, Paul Mahoney, Gordon Leung, Ilie Barb, Mubashir Mumtaz, Kendra Grubb, Eli Gelfand, William Chung, Conrad Vial, Gregory Fontana, Amy Simone, Joseph Newton, Andrew Rassi, Alice Kim, Daniel Harland, David Corteville, Steven Yakubov, Mani Vannan, Akil Loli, Ron Waksman, Heather Reed, Justin Strote, Philippe Genereux, S. Jacob Scheinerman, James Harkness, Steven Bolling, Renuka Jain, Samir Kapadia, Leonard Lee, Kamran Muhammad, Tsuyoshi Kaneko, Linda Gillam, Aidan Raney, Robert Shull, Jeffrey Popma, David Loran, Mark Larralde, Vijay Iyer, Tamim Nazif, Marvin Atkins, Erin Coglianese, Brian Forrestal, Andreas Brieke, Nirat Beohar, Lowell Satler, Khaled Salhab, Neal Duggal, Gorav Ailawadi, Albert Cheung, Moody Makar, Hassan Nemeh, Bethany Austin, Andres Fernandez, Gurpreet Sodhi, William Fearon, Hamang Patel, Troy Leo, Pamela Craven, Ethan Korngold, William Hiesinger, Jacob Mishell, Leo Simpson, Bruce Haik, Joseph Choo, David Snipelisky, Mary Meneses, Christian Spies, Sreekumar Subramanian, Satish Chacko, Preetham Kumar, Evin Yucel, Daniel Menees, Robert Smith, Charles Davidson, David Lange, Matthew Chung, Patrick Bering, Craig Walsh, Eric Kirker, Piotr Sobieszczyk, Vivian Ng, Anthony Panos, Victor Marinescu, Mark Guadagnoli, David Lasorda, Steven Duff, Sanjeev Gulati, Stanley Fernandez, Michael Ingram, Susheel Kodali, Wayne Leimbach, J. Russell Davis, Suhail Allaqaband, Mark Goodwin, Richard W Smalling, Sasan Raissi, Robert Kipperman, Gregory Lewis, Nathan Howard Kander, Lance Sullenberger, Katie Hawthorne, Joseph Mishkin, Edward Gill, Steve Xydas, Victor Farah, Clement Eiswirth, Matthew Romano, Mark Russo, Abbas Bitar, Philip Gideon, Stephen Huddleston, Wilson E Kemp, Georg Mackensen, Tristan Dow, Mohammad El-Hajjar, Brian Kolski, Dustin Lloyd, Omar Khalique, Andrei Churyla, Steven Burstein, Holly Gonzales, Kelly Schlendorf, Varun Khanna, Colin Barker, Michael Main, Mohamad Lazkani, Parag Patel, Andrew D Berke, James Chang, Wilson Szeto, James Kauten, Neal Kleiman, Paul Grayburn, Jeffrey Sparling, Wen Cheng, Mamoo Nakamura, Nathaniel Langer, Thomas Johnston, Feroze Mahmood, Mitul Kadakia, William Gray, Travis Warner, Sandhya Murthy, Esteban Escolar, Rahul Sakhuja, John Trevor Posenau, Kushagra Katariya, Mitchell Timmons, Andrew Sampson, Mackram Eleid, Guy Reeder, Vijendra Swarup, Ramona Davis, Patrick Gleason, Chad A Kliger, Selim Krim, Andrew Lenneman, William Stephan, Richard Jacaruso, Nickalaus Gramze, Kevin Accola, Eric Skipper, Jessica Funk, Stacy Mandras, Rachel Hughes-Doichev, Patrick Ryan, Stephen Clayson, Homam Ibrahim, John Tyner, Charanjit Rihal, Molly Szerlip, Newell B Robinson, Mohammad Bashir, Duc Thinh Pham, Michael A Morse, Pinak Shah, David Liang, Roberto Rodriguez, James Yun, Terri Stewart-Dehner, Joseph Cleveland, Ashish Rastogi, Michael Reardon, Arminder Jassar, Sidakpal Panaich, Taylor Tang, Jonathan Passeri, Mias Pretorius, Siddharth Singh, Nadeen Faza, Hansie Methelier, Courtney Lucyk, Abhijeet Dhoble, Gregory Rushing, Vasilis Babaliaros, Toby Rogers, David Lee, Firas Zahr, Alexander Weymann, David Huneycutt, Stanley Clark, Mithun Chakravarthy, Kenneth Liao, Alfredo Trento, Philip Faraci, Matthew Lander, Saibal Kar, John Riddick, Rahul Sharma, James Thomas, Vinod Thourani, Marvin Eng, Marat Yanavitski, Eric Weiss, Eyal Porat, Srikanth Koneru, Apurva Patel, Elana Koss, Kenneth Huber, Bruce Macrum, Evelio Rodriguez, Stephen Ramee, Konstantinos Boudoulas, Hagen Gorki, Marie France Poulin, Carlos Encarnacion, Oana Petrescu, Mark Douthit, Michael Rinaldi, Ajay Srivastava, Deepa Iyer, Jose Navia, Prakash Balan, Phillip Anderson, Peter Flueckiger, Vishal Parikh, Robert W Hodson, Anthony Magalski, Juan Crestanello, Stephanie Coulter, Bipul Baibhav, Ahmad Sheikh, Andrew Goodman, David Scott Lim, Emad Hakemi, Jyothy Puthumana, Michael Baker, Rajakrishnan Vijayakrishnan, Sandra Abramson, Mohammad Ghani, Craig Asher, William Carlson, David Heimansohn, Mustafa Ahmed, Markus Scherer, Jonathan Schwartz, Hursh Naik, Duane Pinto, David Fullerton, James Gramm, David Vanhooser, Richard Schwartz, Hemal Gada, John Williams, Hoda Butrous, Jonathan Zaroff, Howard Herrmann, Akhil Narang, Sammy Elmariah, Louis Chu, Pei-Hsiu Huang, Paul Coady, Ian Sarembock, Nipun Arora, Jessica Perry, Adnan Chhatriwalla, Theodore Frank, Isaac George, Scott Chadderdon, Lin Wang, Torsten Vahl, John Brown, Aken Desai, Ashraf Sabe, Christian Shults, Garrick Stewart, George A Petrossian, Daniel Donohue, Vibhav Rangarajan, John Tulloch, Amit Vora, Deyanira Prastein, Vivek Rajagopal, Ann Tong, Mario Castillo-Sang, Kent Jones, David Adler, Bruce Bowers, Mark Ricciardi, Ramesh Kundur, David Skolnick, Panayotis Vardas, Michael Slack, Bruce Rutkin, Linda Cadaret, Vishva Dev, Roger Laham, Brian Lindman, Rebecca Hahn, Mei Chau, Arash Arshi, Atizazul Mansoor, Matthew Price, William O'Neil, Zi-Jian Xu, Troy LaBounty, James D Rossen, Sabha Bhatti, Sameh Sayfo, John B Biglane, Nirav C Patel, Christos Mihos, Luigi Pirelli, Stephen Treat, Brett Sheridan, Patrick Parrino, Geoffrey Rose, Sina Moainie, Tarun Chakravarty, Adam Greenbaum, Maria Rosa Costanzo, Ratnasari Padang, Scot Brewster, James Lai, Jack Boyd, Itzhak Kronzon, Susan O'Neil, Keith Allen, David Roberts, Michael Phillips, Terrie-Ann Benjamin, Raed Alnajjar, Konstantine Tzimas, Jose Arias, Chanderdeep Singh, Senthil Nathan, Thomas Kim, Mark Bodenhamer, Andrew Zurick, Georgianne Tokarchik, Nora Rochor, Bakary Camara, Nikhil Jaik, Erwan Salaun, Alexander Tamm, Fabian aus dem Siepen, Jörg Ender, Niklas Schofer, Mirjam Keßler, Dominic Schwab, Felix Kreidel, Erik Bagaev, Philipp Schlegel, Matthias Eden, Michael Näbauer, Felix Heidrich, Roman Pfister, Angela Kornberger, Kavous Hakim-Meibodi, Marcus Sandri, Hazem Omran, Sebastian Sadoni, Jinny Scheffler, Fabian Roder, Peter Boekstegers, Bastian Schmack, Norman Mangner, Krunoslav M Sveric, Nobuyuki Furukawa, Stanislav Keranov, Niklas Boeder, Marcel Halbach, Steffen Desch, Holger Nef, Peter Ludike, Johannes Schirmer, Harald Beucher, Dorit Knappe, Christian Besler, Maximilian von Roeder, Michael Kreußer, Kim O'Connor, Christos Iliadis, Ralph Stephan von Bardeleben, Philipp Lurz, Tienush Rassaf, Mathew Williams, Christian Binner, Lenard Conradi, Hendrik Treede, Jörg Hausleiter, Thomas Johannes Stocker, Rene Schramm, Matthias Lerche, Tobias Ruf, Henrik ten Freyhaus, Peter Clemmensen, Julius Nikorowitsch, Daniel Kalbacher, Matthias Riebisch, Muhammed Gercek, Matthias Groger, Werner Scholtz, Lara Waldschmidt, Birgit Assmus, Georg Stachel, Ludwig Weckbach, Mathias Konstandin, Kai Friedrichs, Christoph Sinning, Alexander Lind, Peter Roth, Philip Raake, Annika Klar, Tillman Dahme, Florian Blachutzik, Christian Liewald, Volker Rudolph, Matthias Bayer, Rawa Arif, Christian Pflücke, Stephan Baldus, Sinisa Markovic, Silke John, Sabine Bleiziffer, Dominik Buckert, Utz Kappert, Eric Dumont, Sven Peterss, Ephraim Winzer, Gregor Warnecke, Christine Reichart, Elmar Kuhn, Korinna Feldmann, Markus Vosseler, Stefanie Hendricks, Martin Volz, Ziya Kaya, Max Potratz, Martin Oberhoffer, Ines Richter, Philipp Kiefer, Martin Geyer, Thilo Noack, John Carroll, Geoff Wilson, Abdullah Alkhadair, Askhay Bagai, Stephen Romero, Russel Stanten, Alberto Alperi-Garcia, David Del Van Martin, James Garnett, David Daniels, Philip Wenzel, Mohammed Latib, Andrew Gohbrial, William Brit-Smith, Patricia Chevez, Lasha Gortamashuili, Pradeep Yadavs, W. Morris Brown, Arseniy Goncharov, David Richards, Peter Moritz-Becher, Fabian J Brunner, Tom C Nguyen, Lars Michel, Birgit Abmus, Stephen Haussig, Konstantinos Alexiou, Nicholas Raio, Goerg Ende, Federico De Puy, Leonhard Moritz-Schneider, Abdul Hannan-Chaugle, Amir-Abbas Mahabadi, Roberto Hodara, Amisha Patel, Jeffery Garrett, Stephen Jenkins, Todd Zwink, Nicoletta Nita, Mirjam Kebler, Maria-Theresa Harris, Florian Fahr, Nicole Tran, Carmine Bevilacqua, Lukas Hunziker Munsch, Rolf Hampel-Landsberg, A. Michael Borkon, Sam Baradarian, Simon Distelmeier, Marion Zimmer, Abdel Karim Al-Ghaddioui, Natalia Wojtkowski, Amir Gahremanpour, Johannes Rotta detto Loria, Anna Flo Forner, Monique Bruwer, Ricardo Spampinato, Gabriel Aldea, Angela Rivera, Matthias Aurich, Danilo Obradovic, Robert Boone, Robert Moss, Jeff Popma, Joe Rahman, Daniel-Sebastian Dohle, Jeremy Edwards, Jacob Dal-Bianco, Gordon Moe, David Reineke, Mark Hensey, Joanna Bartkowiak, Nicolas Brugger, Andrea Ruberti, Mathieu Bernier, Jonathan Beaudoin, Tomasz Gilis-Januszewski, Howard Song, Mathias Orban, Fabien Praz, Edith Lubos, Douglas Horstmanshof, Neil Fam, Geraldine Ong, Harsh Golwala, Daryoush Samim, Wolfgang Rottbauer, Manuel Reyes, Ignacio Inglessis-Azuaje, Nicolas Geis, Thomas Heywood, Tanja Rudolph, Mateo Marin-Cuartas, Carlos Sanchez, S. Chris Malaisrie, John Webb, V. Erick Thompson, Mark Peterson, Josep Rodés-Cabau, Ernesto Ruiz Duque, Christopher Meduri, Tanvir Bajwa, Francois Dagenais, Daniel Braun, Kim Connelly, Axel Linke, Stephan Windecker, David Orsinelli, Jian Ye, Massimiliano Meineri, Raj Makkar, James Lee, Scott Lim, Maria Ivannikova, Prof. Ralph von Bardeleben, Theresa Gossler, Chiowan Hahn, Jennifer Maryam von Stein, Lorenz Lehmann, Holger Thiele, Walter McGregor, Thomas McRae, Sara Mobasseri, Ivan Arenas, Benjamin DeMoss, Jaqueline Grace da Rocha e Silva, John Petersen, J. Bradley Oldemeyer, Tim Rohman, Howard Hermann, Enrique Garcia-Sayan, Nasrien Ibrahim, Dee Dee Wang
Sponsors
Leads: Edwards Lifesciences

This content was sourced from clinicaltrials.gov

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