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 (56) locations...
Intervention Type: Drug, Device
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: No
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
California
SCPMG - Kaiser San Diego
Recruiting
La Jolla
UCLA Medical Center
Recruiting
Los Angeles
Kaiser Permanente San Francisco
Recruiting
San Francisco
Stanford University
Recruiting
Stanford
Colorado
Medical Center of the Rockies
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
Georgia
Emory University Hospital Midtown / Emory University - St. Joseph's Hospital
Recruiting
Atlanta
Iowa
University of Iowa Hospitals & Clinics
Recruiting
Iowa City
Illinois
Northwestern University
Recruiting
Chicago
Indiana
Ascension St. Vincent Heart Center Cardiovascular Research Institute
Recruiting
Indianapolis
Louisiana
Ochsner Medical Center
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
St. Mary's of Ascension Research
Recruiting
Saginaw
Minnesota
Fairview Health Services
Recruiting
Maplewood
Mayo Clinic
Recruiting
Rochester
Missouri
Saint Luke's Hospital of Kansas City
Recruiting
Kansas City
Washington University School of Medicine
Recruiting
Saint Louis
Montana
Providence St. Patrick Hospital
Recruiting
Missoula
North Dakota
Sanford Medical Center Fargo
Recruiting
Fargo
New Hampshire
Dartmouth-Hitchcock Medical Center
Recruiting
Lebanon
New Jersey
Morristown Medical Center
Recruiting
Morristown
Rutgers Robert Wood Johnson Medical School
Recruiting
New Brunswick
New York
Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital
Recruiting
Bronx
State University of New York at Buffalo
Recruiting
Buffalo
Columbia University Irving Medical Center/NYPH
Recruiting
New York
Lenox Hill Hospital, Northwell Health
Recruiting
New York
Weill Cornell Medicine
Recruiting
New York
Rochester General Hospital
Recruiting
Rochester
St. Francis Hospital
Recruiting
Roslyn
Ohio
TriHealth-Bethesda North Hospital
Recruiting
Cincinnati
The Ohio State University
Recruiting
Columbus
Oklahoma
Integris Baptist Medical Center
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
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
Tennessee
Erlanger Health System
Recruiting
Chattanooga
Vanderbilt University Medical Center
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
Virginia
University of Virginia Health System
Recruiting
Charlottesville
Virginia Commonwealth University
Recruiting
Richmond
Carilion Clinic
Recruiting
Roanoke
Wisconsin
Medical College of Wisconsin
Recruiting
Milwaukee
Other Locations
Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Recruiting
Québec
Contact Information
Primary
Edwards TMTT Clinical Affairs
TMTT_Clinical@edwards.com
(949) 250-2500
Time Frame
Start Date: December 11, 2019
Estimated Completion Date: March 2029
Participants
Target number of participants: 825
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
Authors
Todd Forster, Eric Yang, Jana Svetlichnaya, Guilherme Silva, Ashish Shah, Aubrey Hall, Anthony Estrera, Ravi Shah, George Chrysant, Paul Fiorilli, J. Stephen Jenkins, William Smith, Salima Qamruddin, Timothy Lee, Phillip A. Horwitz, William Martin, Jeremiah Depta, Taiyeb Khumri, Abdul Hakeem, Jamil Aboulhosn, Keyur Shah, Gene Chang, Mark Reisman, Caroline Ong, Louis Brunsting III, Marc Sintek, Timothy George, Ashok Chaudhary, Ramzi El Accaoui, Marwan Jumean, Igor Palacios, Stanley Chetcuti, Charles Klodell, Sateesh Kesari, Jon P. Blaschke, Ismail Bekdash, Konstantinos Charitakis, Scott Goldman, Kimberly Staffey, David Majure, Hem Bhardwaj, Chun Kwan, Konstantinos Koulogiannis, Nimesh Desai, Richard Shemin, Jessica Silveri, Mudassar Ahmed, John Saxon, Kelly Chewning, Mirela Tuzovic, Stephen Spindel, Mayra Guerrero, Melissa Smallfield, Brian Corbally, Richard Devereux, Chetan Huded, Jorge Fuentes, Jeffrey Miller, Tiberio Frisoli, Nishtha Sodhi, Pranav Loyalka, Igor Gregoric, Thomas Zeyl, James Hermiller, Kashish Goel, Ivy Ku, Thura Harfi, Priti Mehla, Parmanand Singh, George Hanzel, Jovan Bozinovski, Gordon Leung, Ilie Barb, Mubashir Mumtaz, Kendra Grubb, Jennifer Chen, William Chung, Jennifer Jantz, Zuyue Wang, Stephanie Mick, Andrew Rassi, Ashwin Ravichandran, David Corteville, Tiffany Chen, Jeannette Lin, Craig Basman, Jeffrey Poynter, Mohammed Quader, Steven Macheers, Jeremy Thaden, Heather Reed, Mathew Good, Justin Strote, Gabriel Vorobiof, Philippe Genereux, S. Jacob Scheinerman, Steven Bolling, Harold Roberts, Kamran Muhammad, Arun Singhal, Frank Green, Joggy George, Paul Pearson, David Loran, Isida Byku, Mark Larralde, Shivak Sharma, Vijay Iyer, Erin Coglianese, Nirat Beohar, Neal Duggal, Gorav Ailawadi, Bethany Austin, Eric Gnall, Douglas Segar, Asvin Ganapathi, Hamang Patel, Christiane Haeffele, Pamela Craven, Charles C. Elkins, Safwan Kassas, Jacob Mishell, Inna Tchoukina, Leo Simpson, Bruce Haik, Jordan Hoffman, Jill Hankey, Biswajit Kar, Eileen Daetsch, Evin Yucel, Steven Park, Daniel Spoon, Megan Coylewright, Daniel Menees, Nahush Mokadam, Michael Salerno, Patrick Stevens, Robert L. Smith, Charles Davidson, David Lange, Tarek Absi, Dhaval Kolte, Julie Martin, Anthony Panos, Mark Guadagnoli, Naveed Naz, Sula Mazimba, Stanley Fernandez, Udhay Krishnan, Susheel Kodali, Wayne Leimbach, Sachin Kumar, J. Russell Davis, Olcay Aksoy, Randall Vagelos, Richard Smalling, Mark Joseph, Richard Cooke, Robert Kipperman, Jenny Papazian, Katie Hawthorne, Alan Zajarias, Steve Xydas, Joshua Meskin, Clement Eiswirth, R. Mark Bodenhamer, Matthew Romano, Sharon B. Larson, Mark Russo, Isabelle Hatfield, Abbas Bitar, Stephen Huddleston, Abhinav Sharma, Tristan Dow, Amirali Masoumi, Omar Khalique, Ulrich Jorde, Holly Gonzales, Frank Silvestry, Gregory Dadekian, Thomas Cimato, Kelly Schlendorf, Varun Khanna, Colin Barker, Michael Main, Robert Minutello, Mohamad Lazkani, Benjamin Havens, Biana Trost, Maria Karas, Daniel Pauly, Wilson Szeto, Alexander Iribarne, Paul Grayburn, Jeffrey Sparling, Ajit Tharakan, Nathaniel Langer, Divya Gupta, William Gray, Bahram Khadivi, Vuyisile Nkomo, Sandhya Murthy, Mohamed A. Latib, Esteban Escolar, Rahul Sakhuja, Michael J. Mack, Sukhdeep Basra, Mitchell Timmons, Andrew Sampson, Mackram Eleid, Basel Ramlawi, Barbara Lawson, Martin B. Leon, Jiwon Kim, Patrick Gleason, Sirish Vullaganti, Chad Kliger, Selim Krim, Serguei Melnitchouk, Puja Kachroo, Ali Nsair, Gerin Stevens, Charanjit Rihal, Sorin Pislaru, Deepa Raghunathan, Molly Szerlip, Newell B Robinson, Mohammad Bashir, David H. Liang, John Lasala, Thomas Haldis, Roberto Rodriguez, Lucas Mitchel, Jeffrey Garrett, Lucia Alvarez, Arminder Jassar, Sidakpal Panaich, Jonathan Passeri, Mias Pretorius, Marc Goldschmidt, Aasim Afzal, Abhijeet Dhoble, Angelo Nascimbene, Ankur Sethi, Emily Wandel, Vasilis Babaliaros, Hector Michelena, James Maddux, David P. Lee, Hao Pan, Firas Zahr, Kenneth Liao, Eric Okum, Randolph Panetta, Gentian Lluri, Rahul Sharma, Rafael Garcia-Cortes, Marvin Eng, Marat Yanavitski, Eyal Porat, Carmen Salmon, Srikanth Koneru, Stephen Ramee, Konstantinos Boudoulas, David Axline, Justin Halbe, Zachary Gertz, Deepa Iyer, James DeVries, Robert Guyton, Manish Patel, Lance Richards, Anthony Magalski, Stephanie Coulter, Bipul Baibhav, Ahmad Sheikh, Marrick Kukin, Melana Yuzefpolskaya, Michael Young, Jyothy Puthumana, Michael Baker, Jason Foerst, Sandra Abramson, Mohammad Ghani, Irina Sobol, William Carlson, David Heimansohn, Evelyn Horn, Rani Hasan, Rita Jermyn, Lisa Long, Megan Joseph, Peter Mason, Kerrilynn Hennessey, Peter Fattal, Cornelius Dyke, Leo Marcoff, David Vanhooser, David Ishizawar, Melissa Levack, Bledi Zaku, Hemal Gada, Michael Cash, John M. Williams, Jonathan Zaroff, Gaetano Paone, Sriram Nathan, Howard Herrmann, Sammy Elmariah, Nunzio Gaglianello, Paul Coady, Joseph Coselli, Sunil Mankad, James Slater, Ourania Preventza, Stephanie Khouw, Ythan Goldberg, Jessica Perry, Adnan Chhatriwalla, Isaac George, Scott Chadderdon, Van Selby, Lin Wang, John Brown, Sitaramesh Emani, Lawrence Sinak, George A Petrossian, Geoffrey Bergman, John Tulloch, Amit Vora, Aman M. Shah, Brian Solomon, Matthew Nayor, Ann Tong, Johannes Steiner, Marcella Press, David Skolnick, Linda Cadaret, Brian R. Lindman, Abhishek Singh, Katherine Rajotte, Rebecca Hahn, Peyman Benharash, Mei Chau, Atizazul Mansoor, James D. Rossen, Sameh Sayfo, James Doolittle, Nirav C Patel, Viacheslav Bobovnikov, Noelle Garster, Christos Mihos, Luigi Pirelli, Stephen Treat, Ricardo Yaryura, Patrick Parrino, Sina Moainie, Kamal Shemisa, Adam Greenbaum, Antonio Chiricolo, Chris Liakonis, Ratnasari Sari Padang, John W. MacArthur, Steven Domsky, Roy Arjoon, Homeyar Dinshaw, John Stulak, Shawn Ahmad, Jack Boyd, Susan O'Neil, Keith Allen, Kelley Hutcheson, Brian Walton, Michael Phillips, Terrie-Ann Benjamin, Mohammed Al-Amoodi, Konstantine Tzimas, Steven Debeer, Benoit Labbe, Hashmat M. Ashraf, Georgianne Tokarchik, Erwan Salaun, Susan Graham, Kim O'Connor, Edwin Ho, Marick Kukin, Katerine Rajotte, Chris Magovern, Angelo LaPietra, Khue Ton, Brad Oldemeyer, Lauren Ferris, Dharmendra Patel, Roberto Hodara, Brian O' Neill, Kimberly Frye, Yvonne Gililland, Mohamad Aikhouli, Nicole Tran, Catherine Wong, Abdul H. Chaugle, Grace Lin, Sam Baradarian, Parntip Lai, Deyanira Prastine, Merrill Stewart, Carlos Miranda, Krishnasree Rao, Rajeev Sudhaker, Jacob Dal-Bianco, Élisabeth Bédard, Chandan Devireddy, Joseph Englert, Shirin Jimenez, Mathieu Bernier, Jonathan Beaudoin, Ignacio Inglessis, Howard Song, Lauren Gilstrap, Gabriel Improvola, Aaron Schlegle, Brent White, Alex Cardenas, Douglas Horstmanshof, Harsh Golwala, Karim Al-Azizi, Robert Cubeddu, Ajay Vallakati, Alexis Shafii, S. Chris Malaisrie, Sapna Desai, Andrew Harris, Josep Rodés-Cabau, Ernesto Ruiz Duque, Francois Dagenais, Bryan Whitson, David Orsinelli, Hansie Mathelier, Pedro Villablanca, Vicente Orozco-Sevilla, Erin Iannacone, Scott Lilly, James Lee, Scott Lim, Viviana Navas, Christopher Droogan, Margaret Emmons, William O' Neill, Shing Chiu Wong, Ivan Arenas, Chunguang Chen, Susan P. D'Anna, Enrique Garcia-Sayan, Jose T. Soto, Heeraimangalore Manjunath, Dee Dee Wang
Sponsors
Leads: Edwards Lifesciences

This content was sourced from clinicaltrials.gov