A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
Status: Recruiting
Location: See all (79) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Eighteen (18) years of age or older
• Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
• Severe or greater tricuspid regurgitation
• New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
• Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
• Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements
Locations
United States
Arizona
Banner University Medical Center Phoenix
ACTIVE_NOT_RECRUITING
Phoenix
Tucson Medical Center Healthcare
ACTIVE_NOT_RECRUITING
Tucson
California
University of California, Irvine
RECRUITING
Irvine
SCPMG - Kaiser San Diego
ACTIVE_NOT_RECRUITING
La Jolla
Cedars Sinai Medical Center
RECRUITING
Los Angeles
UCLA Medical Center
RECRUITING
Los Angeles
Kaiser Permanente San Francisco
ACTIVE_NOT_RECRUITING
San Francisco
University of California, San Francisco
RECRUITING
San Francisco
Stanford University
ACTIVE_NOT_RECRUITING
Stanford
Colorado
St. Joseph Hospital
RECRUITING
Denver
Medical Center of the Rockies
ACTIVE_NOT_RECRUITING
Loveland
Florida
The Cardiac and Vascular Institute Research Foundation
RECRUITING
Gainesville
Mount Sinai Medical Center
RECRUITING
Miami Beach
NCH Healthcare System
RECRUITING
Naples
Sarasota Memorial Health Care System
RECRUITING
Sarasota
Tallahassee Research Institute
RECRUITING
Tallahassee
Georgia
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
RECRUITING
Atlanta
Piedmont Healthcare, Inc.
ACTIVE_NOT_RECRUITING
Atlanta
Iowa
University of Iowa Hospitals & Clinics
ACTIVE_NOT_RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Indiana
Ascension St. Vincent Heart Center Cardiovascular Research Institute
RECRUITING
Indianapolis
Louisiana
Ochsner Medical Center
ACTIVE_NOT_RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Johns Hopkins
RECRUITING
Baltimore
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
William Beaumont Hospital - Royal Oak
RECRUITING
Royal Oak
St. Mary's of Ascension Research
ACTIVE_NOT_RECRUITING
Saginaw
Minnesota
Fairview Health Services
ACTIVE_NOT_RECRUITING
Maplewood
Mayo Clinic
RECRUITING
Rochester
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
St Louis
Montana
Providence St. Patrick Hospital
ACTIVE_NOT_RECRUITING
Missoula
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
North Dakota
Sanford Medical Center Fargo
ACTIVE_NOT_RECRUITING
Fargo
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Cooper Health Systems
RECRUITING
Camden
Morristown Medical Center
RECRUITING
Morristown
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
New York
State University of New York at Buffalo
RECRUITING
Buffalo
Columbia University Irving Medical Center/NYPH
RECRUITING
New York
Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Rochester General Hospital
ACTIVE_NOT_RECRUITING
Rochester
St. Francis Hospital
RECRUITING
Roslyn
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
RECRUITING
The Bronx
Ohio
The Christ Hospital
RECRUITING
Cincinnati
TriHealth-Bethesda North Hospital
ACTIVE_NOT_RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Oklahoma
Integris Baptist Medical Center
ACTIVE_NOT_RECRUITING
Oklahoma City
Oklahoma Cardiovascular Research Group
RECRUITING
Oklahoma City
Oklahoma Heart Institute at Hillcrest Medical Center
RECRUITING
Tulsa
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Penn State Hershey
RECRUITING
Hershey
Pennsylvania Presbyterian Medical Center / Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle
RECRUITING
Wormleysburg
Lankenau Heart Institute
RECRUITING
Wynnewood
South Carolina
Medical University of South Carolina
ACTIVE_NOT_RECRUITING
Charleston
Tennessee
Erlanger Health System
ACTIVE_NOT_RECRUITING
Chattanooga
Vanderbilt University Medical Center
ACTIVE_NOT_RECRUITING
Nashville
Texas
Baylor College of Medicine St. Luke's Medical Center
RECRUITING
Houston
HCA Houston Healthcare Medical Center
RECRUITING
Houston
The University of Texas Health Science Center at Houston
RECRUITING
Houston
UTHealth/Memorial Hermann Hospital
RECRUITING
Houston
Baylor Scott & White - The Heart Hospital - Plano
RECRUITING
Plano
Utah
Intermountain Medical Center
ACTIVE_NOT_RECRUITING
Murray
St. George Regional Hospital
RECRUITING
St. George
Virginia
University of Virginia Health System
RECRUITING
Charlottesville
Virginia Commonwealth University
ACTIVE_NOT_RECRUITING
Richmond
Carilion Medical Center
RECRUITING
Roanoke
Washington
Swedish Medical Center
RECRUITING
Seattle
Virginia Mason Medical Center
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Canada
Hamilton Health Services
ACTIVE_NOT_RECRUITING
Hamilton
University of Ottawa Heart Institute
ACTIVE_NOT_RECRUITING
Ottawa
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
ACTIVE_NOT_RECRUITING
Québec
St. Michael's Hospital
ACTIVE_NOT_RECRUITING
Toronto
Sunnybrook Health Sciences Centre
ACTIVE_NOT_RECRUITING
Toronto
St. Paul's Hospital
ACTIVE_NOT_RECRUITING
Vancouver
Contact Information
Primary
Edwards TMTT Clinical Affairs
TMTT_Clinical@edwards.com
(949) 250-2500
Time Frame
Start Date: 2019-12-11
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 870
Treatments
Experimental: Edwards PASCAL System & OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Active_comparator: Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Experimental: Single-Arm Registry
Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Experimental: Continued Access Study
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Authors
William O' Neill, Eric Yang, Jana Svetlichnaya, Heeraimangalore Manjunath, Ravi Shah, Anthony Estrera, J. Stephen Jenkins, Salima Qamruddin, Michael Baker, Susan Graham, Jeremiah Depta, Taiyeb Khumri, Jamil Aboulhosn, Marc Sintek, Timothy George, Ashok Chaudhary, Ramzi El Accaoui, Marwan Jumean, Igor Palacios, Ismail Bekdash, Konstantinos Charitakis, Alexis Shafii, Kimberly Staffey, David Majure, Konstantinos Koulogiannis, Richard Shemin, Mudassar Ahmed, Mirela Tuzovic, Brian Corbally, Richard Devereux, Jorge Fuentes, Mohammad Bashir, Tiberio Frisoli, Igor Gregoric, Thomas Zeyl, Kashish Goel, Jeffrey Garrett, Ivy Ku, Vicente Orozco-Sevilla, Scott Goldman, Jovan Bozinovski, Gordon Leung, Jiwon Kim, Kendra Grubb, Jennifer Jantz, Stephanie Mick, Andrew Rassi, Ashwin Ravichandran, Bryan Whitson, Jeannette Lin, Craig Basman, Steven Macheers, Jeremy Thaden, Mathew Good, Justin Strote, Gabriel Vorobiof, S. Jacob Scheinerman, Steven Bolling, Harold Roberts, Ivan Arenas, Frank Green, Joggy George, David Loran, Mark Larralde, Shivak Sharma, Bethany Austin, Eric Gnall, Douglas Segar, Asvin Ganapathi, Christiane Haeffele, Pamela Craven, Safwan Kassas, Howard Song, Jacob Mishell, Erin Iannacone, Leo Simpson, Bruce Haik, Terrie-Ann Benjamin, Evin Yucel, Daniel Spoon, Daniel Menees, Nahush Mokadam, Michael Salerno, David Lange, Tarek Absi, Sam Baradarian, Julie Martin, Mark Guadagnoli, Kim O'Connor, Udhay Krishnan, Wayne Leimbach, Sachin Kumar, J. Russell Davis, Olcay Aksoy, Randall Vagelos, Chunguang Chen, Katie Hawthorne, Clement Eiswirth, R. Mark Bodenhamer, Matthew Romano, Abbas Bitar, Stephen Huddleston, Tristan Dow, Amirali Masoumi, Ulrich Jorde, Holly Gonzales, Gregory Dadekian, Thomas Cimato, Kelly Schlendorf, Varun Khanna, Michael Main, Robert Minutello, Mohamad Lazkani, Maria Karas, Paul Grayburn, Ajit Tharakan, Nathaniel Langer, Bahram Khadivi, Konstantine Tzimas, Vuyisile Nkomo, Esteban Escolar, Rahul Sakhuja, Mitchell Timmons, Andrew Sampson, Basel Ramlawi, Patrick Gleason, Sirish Vullaganti, Chad Kliger, Selim Krim, Serguei Melnitchouk, Ali Nsair, Gerin Stevens, Charanjit Rihal, Sorin Pislaru, Deepa Raghunathan, David H. Liang, John Lasala, David P. Lee, Thomas Haldis, Roberto Rodriguez, Lucas Mitchel, Sidakpal Panaich, Jonathan Passeri, Mias Pretorius, Marc Goldschmidt, Aasim Afzal, Angelo Nascimbene, Ankur Sethi, Vasilis Babaliaros, Hector Michelena, James Maddux, Brian Walton, Kenneth Liao, Randolph Panetta, Gentian Lluri, Rafael Garcia-Cortes, Marat Yanavitski, Eyal Porat, Srikanth Koneru, Stephen Ramee, David Axline, Justin Halbe, Zachary Gertz, Deepa Iyer, James DeVries, Robert Guyton, Lance Richards, Anthony Magalski, Stephanie Coulter, Bipul Baibhav, Ahmad Sheikh, Marrick Kukin, Melana Yuzefpolskaya, Jyothy Puthumana, Sandra Abramson, Irina Sobol, William Carlson, David Heimansohn, Evelyn Horn, Rita Jermyn, Megan Joseph, James Lee, Peter Fattal, Cornelius Dyke, Karim Al-Azizi, Melissa Levack, Bledi Zaku, Michael Cash, John M. Williams, Jonathan Zaroff, Ajay Vallakati, Sriram Nathan, Sammy Elmariah, Paul Coady, Joseph Coselli, Sunil Mankad, Ourania Preventza, Isaac George, Van Selby, Kelley Hutcheson, Sitaramesh Emani, Lawrence Sinak, George A Petrossian, Geoffrey Bergman, John Tulloch, David Orsinelli, Brian Solomon, Matthew Nayor, Ann Tong, James Slater, David Skolnick, Linda Cadaret, Brian R. Lindman, Rebecca Hahn, Peyman Benharash, Atizazul Mansoor, Sameh Sayfo, Viacheslav Bobovnikov, Luigi Pirelli, Stephen Treat, Patrick Parrino, Sina Moainie, Antonio Chiricolo, Chris Liakonis, Ratnasari Sari Padang, John W. MacArthur, Steven Domsky, Homeyar Dinshaw, John Stulak, Shawn Ahmad, Jack Boyd, Erwan Salaun, Erin Coglianese, Aman M. Shah, Arun Singhal, George Hanzel, Biana Trost, Arminder Jassar, Christos Mihos, Sukhdeep Basra, Gaetano Paone, Amit Vora, Marvin Eng, Neal Duggal, Philippe Genereux, Michael Phillips, Alexander Iribarne, Dhaval Kolte, Stephen Spindel, Hao Pan, Ythan Goldberg, Zuyue Wang, Benjamin Havens, Leo Marcoff, Grace Lin, Mark Reisman, Gorav Ailawadi, Anthony Panos, James D. Rossen, Phillip A. Horwitz, Newell B Robinson, Sharon B. Larson, Abhishek Singh, Lucia Alvarez, Isida Byku, Priti Mehla, Sula Mazimba, Parmanand Singh, Nishtha Sodhi, Edwin Ho, Kerrilynn Hennessey, Jonathan Beaudoin, Francois Dagenais, Josep Rodés-Cabau, Mathieu Bernier, Sapna Desai, Élisabeth Bédard
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences