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 (100) 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: f
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 corrected BNP \> 400 pg/ml or corrected NT-pro BNP of \> 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)

• LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)

Locations
United States
Alabama
The University of Alabama at Birmingham
WITHDRAWN
Birmingham
Arizona
Abrazo Arizona Heart Hospital
RECRUITING
Phoenix
Arizona Cardiovascular Research Center
WITHDRAWN
Phoenix
Banner University Medical Center
RECRUITING
Phoenix
TMC Healthcare
RECRUITING
Tucson
California
Scripps Memorial Hospital La Jolla
RECRUITING
La Jolla
Cedars Sinai Medical Center
RECRUITING
Los Angeles
PIH Health Good Samaritan Hospital
WITHDRAWN
Los Angeles
St. Joseph Hospital
WITHDRAWN
Orange
UC Irvine
RECRUITING
Orange
Sutter Medical Center-Sacramento
RECRUITING
Sacramento
UC Davis Medical Center
WITHDRAWN
Sacramento
Kaiser Permanente San Francisco
RECRUITING
San Francisco
Sutter Bay Area
ACTIVE_NOT_RECRUITING
San Francisco
University of California, San Francisco
RECRUITING
San Francisco
Stanford University
RECRUITING
Stanford
Los Robles Hospital and Medical Center
RECRUITING
Thousand Oaks
Colorado
University of Colorado Hospital
WITHDRAWN
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
NCH Healthcare System Naples
RECRUITING
Naples
AdventHealth Orlando
RECRUITING
Orlando
Cleveland Clinic Florida
WITHDRAWN
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
Carmel
Kansas
Cardiovascular Research Institute of Kansas
WITHDRAWN
Wichita
Louisiana
Ochsner Medical Center
WITHDRAWN
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
WITHDRAWN
Maplewood
Mayo Clinic
RECRUITING
Rochester
Missouri
St.Luke's Hospital of Kansas City
RECRUITING
Kansas City
Washington University/Barnes Jewish Hospital
RECRUITING
Saint Louis
North Carolina
Atrium Health/Sanger Heart & Vascular Institute
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 Langone Hospital - Long Island
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
WITHDRAWN
Columbus
The Ohio State University Medical Center
WITHDRAWN
Columbus
Oklahoma
Integris Health Baptist Medical Center
WITHDRAWN
Oklahoma City
Oklahoma Cardiovascular
RECRUITING
Oklahoma City
Oklahoma Heart Institute
RECRUITING
Tulsa
Oregon
Oregon Health & Science University
RECRUITING
Portland
Providence St. Vincent Medical Center
WITHDRAWN
Portland
Pennsylvania
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
RECRUITING
Philadelphia
Allegheny General Hospital
ACTIVE_NOT_RECRUITING
Pittsburgh
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
RECRUITING
Wormleysburg
Lankenau Medical Center
RECRUITING
Wynnewood
Tennessee
Baptist Memorial Hospital Memphis
RECRUITING
Memphis
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
WITHDRAWN
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: 2018-11-30
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 1247
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
Arseniy Goncharov, George Gubernikoff, Selma Mohammed, Guilherme Silva, Anthony Estrera, Devin Kehl, Richard Ericson, Mustafa Ahmed, George Chrysant, Venkateshwar Polsani, Nader Makki, Mark Russo, Eugene Pashkovetsky, S. Chris Malaisrie, Hector Ventura, David Aliabadi, Tomomi Oka, Robert Quaife, Jean-Michel Paradis, Brett E Grizzell, Timothy George, Hassan Sayegh, Mustafa Toma, Naveen Saha, Ramzi El Accaoui, Igor Palacios, Rajeev Mohan, Kamal Khabbaz, Eric Lehr, Todd Dewey, Jon Blaschke, Erum Bajwa, Kimberly Staffey, Sunu Thomas, Mudassar Ahmed, Brandon Jones, Cezar Staniloae, Michael Slack, Nasir Sulemanjee, Mohammad Bashir, Serge Harb, Aman Ali, Tiberio Frisoli, Lin Wang, Steven Voskanian, Vinayak Bapat, Thomas Zeyl, Kashish Goel, Merick Kirshner, Danny Ramzy, Ivy Ku, Paul Mahoney, Gordon Leung, Ilie Barb, Eli Gelfand, Conrad Vial, Gregory Fontana, Joseph Newton, Raed Alnajjar, Daniel Harland, Steven Yakubov, Mani Vannan, Akil Loli, Justin Strote, S. Jacob Scheinerman, Steven Bolling, Renuka Jain, Ivan Arenas, Leonard Lee, Tsuyoshi Kaneko, Sara Mobasseri, Aidan Raney, Jeffrey Popma, David Loran, Mark Larralde, Tanvir Bajwa, Tamim Nazif, Marvin Atkins, Brian Forrestal, Andreas Brieke, Khaled Salhab, Albert Cheung, Moody Makar, Hassan Nemeh, Bethany Austin, Gurpreet Sodhi, William Fearon, Troy Leo, Pamela Craven, Ethan Korngold, Jacob Mishell, Leo Simpson, Bruce Haik, Terrie-Ann Benjamin, David Roberts, Joseph Choo, Christian Spies, Sreekumar Subramanian, Satish Chacko, Evin Yucel, Daniel Menees, Patrick Bering, Craig Walsh, Eric Kirker, Sam Baradarian, Vivian Ng, Victor Marinescu, Mark Guadagnoli, Kim O'Connor, David Lasorda, Steven Duff, Sanjeev Gulati, Wayne Leimbach, J. Russell Davis, Parag Patel, Jonathan Schwartz, James Lee, Sasan Raissi, Gregory Lewis, Nathan Howard Kander, Lance Sullenberger, Katie Hawthorne, Joseph Mishkin, Victor Farah, Clement Eiswirth, Matthew Romano, Abbas Bitar, Philip Gideon, Stephen Huddleston, Georg Mackensen, Tristan Dow, Brian Kolski, Omar Khalique, Andrei Churyla, Steven Burstein, Andrew Zurick, Holly Gonzales, Kelly Schlendorf, Varun Khanna, Michael Main, Rahul Sharma, Duc Thinh Pham, James Chang, Wilson Szeto, James Kauten, Paul Grayburn, Jeffrey Sparling, Mamoo Nakamura, Nathaniel Langer, Mitul Kadakia, Stephen Bailey, Konstantine Tzimas, Esteban Escolar, Rahul Sakhuja, Kushagra Katariya, Ming Zhang, Mitchell Timmons, Andrew Sampson, Guy Reeder, David Richards, Patrick Gleason, Selim Krim, Andrew Lenneman, William Stephan, Richard Jacaruso, Nickalaus Gramze, Eric Skipper, Stacy Mandras, Rachel Hughes-Doichev, Christopher Meduri, Patrick Ryan, Stephen Clayson, John Tyner, Charanjit Rihal, Augustin Delago, Terri Stewart-Dehner, Joseph Cleveland, Sidakpal Panaich, Jonathan Passeri, Mias Pretorius, Nadeen Faza, Manuel Reyes, Hansie Methelier, Gregory Rushing, Vasilis Babaliaros, Toby Rogers, Alexander Weymann, David Huneycutt, Stanley Clark, John Petersen, Mithun Chakravarthy, Kenneth Liao, Alfredo Trento, Philip Faraci, Matthew Lander, Vinod Thourani, Marat Yanavitski, Eyal Porat, Apurva Patel, Elana Koss, Kenneth Huber, Bruce Macrum, Stephen Ramee, Konstantinos Boudoulas, Hagen Gorki, Oana Petrescu, Mark Douthit, Ajay Srivastava, Deepa Iyer, Phillip Anderson, Vishal Parikh, Robert W Hodson, Anthony Magalski, Thomas Kim, Juan Crestanello, Stephanie Coulter, Bipul Baibhav, Ahmad Sheikh, Andrew Goodman, David Scott Lim, Jyothy Puthumana, Sandra Abramson, William Carlson, David Heimansohn, Duane Pinto, David Fullerton, James Gramm, David Vanhooser, Hemal Gada, John Williams, Jonathan Zaroff, Akhil Narang, Louis Chu, Paul Coady, Ian Sarembock, Nipun Arora, Theodore Frank, Scott Chadderdon, Torsten Vahl, John Brown, Aken Desai, Jacob Dal-Bianco, John Tulloch, David Orsinelli, Walter McGregor, Vivek Rajagopal, Ann Tong, Mario Castillo-Sang, Kent Jones, Bruce Bowers, Mark Ricciardi, David Skolnick, Panayotis Vardas, Linda Cadaret, Chanderdeep Singh, Vishva Dev, Rebecca Hahn, Michael Ingram, Arash Arshi, Atizazul Mansoor, Zi-Jian Xu, Sabha Bhatti, Sameh Sayfo, John B Biglane, Luigi Pirelli, Stephen Treat, Brett Sheridan, Patrick Parrino, Geoffrey Rose, Sina Moainie, Tarun Chakravarty, Maria Rosa Costanzo, Ratnasari Padang, Scot Brewster, Edward Gill, Jack Boyd, Erwan Salaun, Alexander Tamm, Jörg Ender, Felix Kreidel, Erik Bagaev, Philipp Schlegel, Michael Näbauer, Felix Heidrich, Roman Pfister, Angela Kornberger, Kavous Hakim-Meibodi, Nicolas Geis, Marcus Sandri, Philip Wenzel, Hazem Omran, Sebastian Sadoni, 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, Christos Iliadis, Ralph von Bardeleben, Tienush Rassaf, Christian Binner, Lenard Conradi, Hendrik Treede, Jörg Hausleiter, Thomas Stocker, Rene Schramm, Tobias Ruf, Henrik ten Freyhaus, Daniel Kalbacher, Matthias Riebisch, Muhammed Gercek, Matthias Gröger, Werner Scholtz, Birgit Assmus, Georg Stachel, Kai Friedrichs, Christoph Sinning, Alexander Lind, Philip Raake, Matthias Bayer, Christian Pflücke, Sinisa Markovic, Silke John, Sabine Bleiziffer, Utz Kappert, Robert Moss, Ephraim Winzer, Gregor Warnecke, Elmar Kuhn, Markus Vosseler, Stefanie Hendricks, Martin Volz, Max Potratz, Martin Oberhoffer, Philipp Kiefer, Martin Geyer, Thilo Noack, Daniel Braun, Bassem M Chehab, Erin Coglianese, Roshin Mathew, Wilson E Kemp, Arminder Jassar, Christos Mihos, Amit Vora, Peter Flueckiger, Hoda Butrous, Neal Duggal, Philippe Genereux, Michael Phillips, Stephen Spindel, Andrew D Berke, Feroze Mahmood, Isaac George, Mei Chau, Bruce Rutkin, Taylor Tang, Hamang Patel, Kendra Grubb, Vibhav Rangarajan, Dustin Lloyd, Gorav Ailawadi, Ron Waksman, Andres Fernandez, Anthony Panos, James D Rossen, Markus Scherer, Christian Shults, Siddharth Singh, Deyanira Prastein, Carlos Encarnacion, Richard W Smalling, James Harkness, Robert Shull, Preetham Kumar, Troy LaBounty, Amar Krishnaswamy, Gene Chang, Samuel Horr, Mohammad El-Hajjar, Rhonda Miyasaka, David Liang, Jeremy Edwards, Gordon Moe, Carmine Bevilacqua, Mark Hensey, Anna Flo Forner, Massimiliano Meineri, Daniel-Sebastian Dohle, Mathieu Bernier, Eric Dumont, Amir-Abbas Mahabadi, Abdul Hakeem, Stephan Windecker, Geraldine Ong, Ricardo Spampinato, Joanna Bartkowiak, Edith Lubos, Holger Thiele, Francois Dagenais, Wolfgang Rottbauer, Kim Connelly, Jian Ye, Mathias Orban, Jonathan Beaudoin, Philipp Lurz, Tanja Rudolph, David Reineke, Nicolas Brugger
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences

This content was sourced from clinicaltrials.gov