Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03706833

Recruitment Status : Recruiting

First Posted : October 16, 2018

Last Update Posted : December 19, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Edwards Lifesciences

Study Description

Brief 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)

Condition or disease	Intervention/treatment	Phase
Degenerative Mitral Valve Disease Mitral Regurgitation Mitral Insufficiency Functional Mitral Regurgitation	Device: Edwards PASCAL System Device: Abbott Mitraclip System	Phase 3

Detailed Description:

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 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)

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1275 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	November 30, 2018
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	January 31, 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: Edwards PASCAL System - CLASP IID Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation	Device: Edwards PASCAL System Transcatheter mitral valve repair with the Edwards PASCAL System Other Name: Transcatheter Mitral Valve repair (TMVr)
Active Comparator: Abbott Mitraclip System - CLASP IID Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation	Device: Abbott Mitraclip System Transcatheter mitral valve repair with the Abbott Mitraclip System Other Name: Transcatheter Mitral Valve repair (TMVr)
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	Device: Edwards PASCAL System Transcatheter mitral valve repair with the Edwards PASCAL System Other Name: Transcatheter Mitral Valve repair (TMVr)
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	Device: Abbott Mitraclip System Transcatheter mitral valve repair with the Abbott Mitraclip System Other Name: Transcatheter Mitral Valve repair (TMVr)

Outcome Measures

Primary Outcome Measures :

PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). [ Time Frame: 30 days. ]
PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+. [ Time Frame: 6 months ]
PASCAL is not inferior to MitraClip with respect to the proportion of patients with recurrent heart failure hospitalizations and all-cause mortality [ Time Frame: 24 months ]

Secondary Outcome Measures :

Rates of various adverse events [ Time Frame: 6 months; 12 months ]
Rates of various adverse events at 6 and 12 months
Functional Improvement (increase in 6 minute walk test in meters) [ Time Frame: 30 days , 6 months, 1 year ]
Increase in 6 minute walk test in meters
Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire [ Time Frame: 30 days , 6 months, 1 year ]
Number of points of improvement in Kansas City Cardiomyopathy Questionnaire
Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire [ Time Frame: 30 days, 6 months, 1 year ]
Number of points of improvement in Short Form Health Survey (SF-36) questionnaire

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
Patient with refractory heart failure requiring advanced intervention (i.e. biventricular pacemakers, left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure)
Clinically significant, untreated coronary artery disease
Recent stroke
Other severe valve disorders requiring intervention
Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
Any prior mitral valve surgery (except surgical annuloplasty) or transcatheter mitral valve procedure
Active rheumatic heart disease or rheumatic etiology for MR
Severe aortic stenosis or regurgitation
Known history of severe symptomatic carotid stenosis
History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
Severe COPD
Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706833

Contacts

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Contact: Edwards TMTT Clinical Affairs	(949) 250-2500	TMTT_Clinical@edwards.com

Locations

Show 73 study locations

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United States, Arizona
TMC Healthcare	Recruiting
Tucson, Arizona, United States, 85712
Contact: Natalia Elias-Calles 520-324-5512 Natalia.eliascalles@tmcaz.com
Contact: Edgardo Soto 520-324-5512 Edgardo.soto@tmcaz.com
Principal Investigator: Thomas Waggoner, DO
Principal Investigator: Neil Gheewala, MD
Sub-Investigator: Nader Makki, MD
Sub-Investigator: Gregory Franklin, MD
Sub-Investigator: Kushagra Katariya, MD
United States, California
Cedars Sinai Medical Center	Recruiting
Los Angeles, California, United States, 90048
Contact: Mitch Gheorghiu 310-423-6152 Mitch.Gheorghiu@cshs.org
Contact: Kelly Salazar 310-967-4375 Kelly.Salazar@cshs.org
Principal Investigator: Raj Makkar, MD
Sub-Investigator: Alfredo Trento, MD
Sub-Investigator: Mamoo Nakamura, MD
Sub-Investigator: Danny Ramzy, MD
Sub-Investigator: Tarun Chakravarty, MD
Sub-Investigator: Wen Cheng, MD
Sub-Investigator: Moody Makar, MD
Sub-Investigator: Siddharth Singh, MD
Sutter Medical Center-Sacramento	Recruiting
Sacramento, California, United States, 95618
Contact: Beverly Seiler, RN 916-887-4173 Seilerb@sutterhealth.org
Contact: Wynell Richardson 916-887-4173 melvinw@sutterhealth.org
Principal Investigator: Pei-Hsiu Huang, MD
Sub-Investigator: Michael Ingram, MD
Sub-Investigator: David Roberts, MD
Sub-Investigator: Zi-Jian Xu, MD
UC Davis Medical Center	Withdrawn
Sacramento, California, United States, 95817
Scripps Memorial Hospital La Jolla	Active, not recruiting
San Diego, California, United States, 92037
Sutter Bay Area	Recruiting
San Francisco, California, United States, 94109
Contact: Milena Ferreira 415-600-5707 FerreiML@sutterhealth.org
Principal Investigator: Christian Spies, MD
Sub-Investigator: Devin Kehl, MD
Sub-Investigator: David Daniels, MD
Sub-Investigator: Mitul Kadakia, MD
Sub-Investigator: James Lai, MD
Sub-Investigator: Brett Sheridan, MD
Sub-Investigator: Conrad Vial, MD
Sub-Investigator: Tomomi Oka, MD
Sub-Investigator: Russel Stanten, MD
Kaiser Permanente San Francisco	Recruiting
San Francisco, California, United States, 94118
Contact: Cristina Casias, RN 415-833-2247 Cristina.Casias@kp.org
Contact: Brenda Le, RN 415-833-2118 Brenda.D.Le@kp.org
Principal Investigator: Andrew Rassi, MD
Sub-Investigator: Jacob Mishell, MD
Sub-Investigator: Vic Melikian, MD
Sub-Investigator: Gordon Leung, MD
Sub-Investigator: Ivy Ku, MD
Sub-Investigator: David Lange, MD
Sub-Investigator: Jonathan Zaroff, MD
Sub-Investigator: Ahmad Sheikh, MD
Stanford University	Recruiting
Stanford, California, United States, 94305
Contact: Tiffany Flores 650-206-3345 Tflores2@stanford.edu
Contact: Rachelle Villanueva 650-721-6241 Rvilla@stanford.edu
Principal Investigator: William Hiesinger, MD
Sub-Investigator: David Lee, MD
Sub-Investigator: Jack Boyd, MD
Sub-Investigator: Rahul Sharma, MD
Sub-Investigator: David Liang, MD
Sub-Investigator: William Fearon, MD
Sub-Investigator: Albert Cheung, MD
Los Robles Hospital and Medical Center	Recruiting
Thousand Oaks, California, United States, 91360
Contact: Mane Arabyan 805-796-3746 Mane.Arabyan@Hcahealthcare.com
Contact: Cherry Papanicolaou 805-368-1803 Cherry.Papanicolaou@Hcahealthcare.com
Principal Investigator: Saibal Kar, MD
Sub-Investigator: David Aliabadi, MD
Sub-Investigator: Philip Faraci, MD
Sub-Investigator: Gregory Fontana, MD
Sub-Investigator: Dustin Lloyd, MD
Sub-Investigator: Andrew Gohbrial, MD
United States, Colorado
University of Colorado Hospital	Recruiting
Aurora, Colorado, United States, 80045
Contact: Austin Daw 303-724-5685 Austin.daw@cuanschutz.edu
Contact: Mercedes Zirbes 720-848-6247 Mercedes.Zirbes@cuanschutz.edu
Principal Investigator: John Carroll, MD
Sub-Investigator: Joseph Cleveland, MD
Sub-Investigator: Andreas Brieke, MD
Sub-Investigator: Edward Gill, MD
Sub-Investigator: Robert Quaife, MD
Medical Center of the Rockies	Recruiting
Loveland, Colorado, United States, 80538
Contact: Justin Strote, MD 970-221-1000 justin.strote@uchealth.org
Contact: Adam Jaskowiak 970-624-1688 adam.jaskowiak@uchealth.org
Principal Investigator: Mohamad Lazkani, MD
Sub-Investigator: Justin Strote, MD
Sub-Investigator: Mark Douthit, MD
Sub-Investigator: Tristan Dow, MD
Sub-Investigator: C. Patrick Green, MD
Sub-Investigator: Mark Guadagnoli, MD
Sub-Investigator: Satish Chacko, MD
Sub-Investigator: J. Bradley Oldemeyer, MD
Sub-Investigator: Stephen Treat, MD
United States, District of Columbia
Medstar Washington Hospital Center	Recruiting
Washington, District of Columbia, United States, 20010
Contact: Caroline Barnes 202-877-0078 caroline.g.barnes@medstar.net
Contact: Michelle Deville 202-877-2713 michelle.deville@medstar.net
Principal Investigator: Lowell Satler, MD
Sub-Investigator: Ron Waksman, MD
Sub-Investigator: Istik Ben-dor, MD
Sub-Investigator: Toby Rogers, MD
Sub-Investigator: Preetham Kumar, MD
Sub-Investigator: Brian Forrestal, MD
Sub-Investigator: Patrick Bering, MD
Sub-Investigator: Michael Slack, MD
United States, Florida
The Cardiac and Vascular Institute Research Foundation	Recruiting
Gainesville, Florida, United States, 32605
Contact: Elizabeth Padgett 352-260-5398 epadgett@tcavi.com
Contact: Abby Foster 352-260-5398 afoster@tcavi.com
Principal Investigator: Charles Klodell, MD
Sub-Investigator: Ilie Barb, MD
Sub-Investigator: Ann Tong, MD
Sub-Investigator: Heather Reed, MD
Sub-Investigator: William Brit-Smith, MD
Sub-Investigator: Aubrey Hall, APRN
Sub-Investigator: Jessica Perry, PA
Sub-Investigator: Angela Rivera, PA
Sub-Investigator: Thomas Zeyl, MD
Sub-Investigator: Kelly Chewning, APRN
Mount Sinai	Recruiting
Miami Beach, Florida, United States, 33140
Contact: Giselle Cortez-Vargas 305-674-2121 ext 56022 Giselle.CortezVargas@msmc.com
Contact: Beatriz Acevedo 305-674-2121 ext 56022 Beatriz.Acevedo@msmc.com
Principal Investigator: Nirat Beohar, MD
Principal Investigator: Steve Xydas, MD
Sub-Investigator: Ivan Arenas, MD
Sub-Investigator: Mark Larralde, MD
Sub-Investigator: Christos Mihos, MD
Sub-Investigator: Esteban Escolar, MD
AdventHealth Orlando	Active, not recruiting
Orlando, Florida, United States, 32803
United States, Georgia
Piedmont Healthcare	Recruiting
Atlanta, Georgia, United States, 30309
Contact: Shelley Holt 404-605-5003 Shelley.Holt@piedmont.org
Contact: Caryn Bernstein 404-605-5688 Caryn.Bernstein@piedmont.org
Principal Investigator: Pradeep Yadavs, MD
Sub-Investigator: James Kauten, MD
Sub-Investigator: W. Morris Brown, MD
Sub-Investigator: Vinod Thourani, MD
Sub-Investigator: Vivek Rajagopal, MD
Sub-Investigator: Christopher Meduri, MD
Sub-Investigator: Benjamin DeMoss, MD
Sub-Investigator: Peter Flueckiger, MD
Sub-Investigator: Sara Mobasseri, MD
Sub-Investigator: Venkateshwar Polsani, MD
Sub-Investigator: Hassan Sayegh, MD
Sub-Investigator: Mani Vannan, MD
Sub-Investigator: Vibhav Rangarajan, MD
Sub-Investigator: Roshin Mathew, MD
Sub-Investigator: Ramona Davis, PA
Sub-Investigator: Amy Simone, PA
Emory University Hospital and Emory University Hospital Midtown	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elizabeth Charles 404-686-1249 Elizabeth.z.charles@emory.edu
Contact: Kristy Pitts 404-686-5775 klpitts@emory.edu
Principal Investigator: Adam Greenbaum, MD
Sub-Investigator: Vasilis Babaliaros, MD
Sub-Investigator: Kendra Grubb, MD
Sub-Investigator: Patrick Gleason, MD
Sub-Investigator: Chandan Deveriddy, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: BCVI Clinical Trials Unit 312-926-4000 heartresearch@northwestern.edu
Principal Investigator: Mark Ricciardi, MD
Sub-Investigator: Charles Davidson, MD
Sub-Investigator: S. Chris Malaisrie, MD
Sub-Investigator: Duc Thinh Pham, MD
Sub-Investigator: Andrei Churyla, MD
Sub-Investigator: James Thomas, MD
Sub-Investigator: Jyothy Puthumana, MD
Sub-Investigator: Anhil Narang, MD
Advocate Health & Hospitals Corp/Edward Heart Hospital	Recruiting
Naperville, Illinois, United States, 60540
Contact: Josilyn Klimek 630-785-2242 Josily.klimek@advocatehealth.com
Contact: Kim Paprockas 630-785-2242 Kimberly.paprockas@advocatehealth.com
Principal Investigator: Mark Goodwin, MD
Principal Investigator: William Stephan, MD
Sub-Investigator: Stanley Clark, MD
Sub-Investigator: Maria Rosa Costanzo, MD
Sub-Investigator: James Gramm, MD
Sub-Investigator: Victor Marinescu, MD
Sub-Investigator: Aman Ali, MD
United States, Indiana
St. Vincent Heart Center	Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Mary Lynn Burkert 317-583-6116 Mary.burkert@ascension.org
Contact: Jana Fisher 317-583-7804 Jana.fisher@ascension.org
Principal Investigator: James B Hermiller, MD
Sub-Investigator: Andrew Sampson, MD
Sub-Investigator: Sina Moainie, MD
Sub-Investigator: David Heimansohn, MD
United States, Kansas
Cardiovascular Research Institute of Kansas	Withdrawn
Wichita, Kansas, United States, 67226
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lina Fu 617-643-1371 Lfu2@partners.org
Contact: Matthew Covello 617-643-1371 Mcovello@partners.org
Principal Investigator: Ignacio Inglessis-Azuaje, MD
Sub-Investigator: Sammy Elmariah, MD
Sub-Investigator: Rahul Sakhuja, MD
Sub-Investigator: Igor Palacios, MD
Sub-Investigator: Arminder Jassar, MD
Sub-Investigator: Nathaniel Langer, MD
Sub-Investigator: Jonathan Passeri, MD
Sub-Investigator: Jacob Dal-Bianco, MD
Sub-Investigator: Evin Yucel, MD
Sub-Investigator: Gregory Lewis, MD
Sub-Investigator: William Carlson, MD
Sub-Investigator: Erin Coglianese, MD
Sub-Investigator: Sunu Thomas, MD
Sub-Investigator: Nasrien Ibrahim, MD
Brigham and Woman's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Downey 617-732-4812 Ldowney2@bwh.harvard.edu
Contact: Brittany Bauman 1-617-525-7072 Bbauman1@bwh.hardvard.edu
Principal Investigator: Pinak Shah, MD
Sub-Investigator: Tsuyoshi Kaneko, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jennifer Kaufman, RN, MS 617-632-8956 jmkaufma@bidmc.harvard.edu
Contact: Trishna Sadhwani, BA 617-632-7485 tsadhwan@bidmc.harvard.edu
Principal Investigator: Roger Laham, MD
Sub-Investigator: Kamal Khabbaz, MD
Sub-Investigator: David C Lui, MD
Sub-Investigator: Senthil Nathan, MD
Sub-Investigator: Louis Chu, MD
Sub-Investigator: Eli Gelfand, MD
Sub-Investigator: Duane Pinto, MD
Sub-Investigator: James Chang, MD
Sub-Investigator: Marie France Poulin, MD
Sub-Investigator: Feroze Mahmood, MD
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jessica Oakley 734-232-9051 joakley@med.umich.edu
Principal Investigator: Stanley Chetcuti, MD
Sub-Investigator: Steven Bolling, MD
Sub-Investigator: Daniel Menees, MD
Sub-Investigator: Matthew Romano, MD
Sub-Investigator: Neal Duggal, MD
Sub-Investigator: Abbas Bitar, MD
Sub-Investigator: Troy LaBounty, MD
Henry Ford Hospital	Recruiting
Detroit, Michigan, United States, 48202
Contact: Ardit Kacorri 313-916-7452 Akacorr1@hfhs.org
Contact: Fanar Razoky 313-916-7455 Frazoky1@hfhs.org
Principal Investigator: William O'Neill, MD
Sub-Investigator: Marvin Eng, MD
Sub-Investigator: Tiberio Frisoli, MD
Sub-Investigator: Dee Dee Wang, MD
Sub-Investigator: James Lee, MD
Sub-Investigator: Hassan Nemeh, MD
Sub-Investigator: Raed Alnajjar, MD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55902
Contact: Amanda Biddle, RN 507-255-6133 Biddle.Amanda@mayo.edu
Contact: Craig Konwinski 507-255-6133 Konwinski.Craig@mayo.edu
Principal Investigator: Mayra Guerrero, MD
Sub-Investigator: Guy Reeder, MD
Sub-Investigator: Charanjit Rihal, MD
Sub-Investigator: Ratnasari Padang, MD
Sub-Investigator: Juan Crestanello, MD
United States, Missouri
St.Luke's Hospital of Kansas City	Recruiting
Kansas City, Missouri, United States, 64111
Contact: Alicia Roberts, RN 816-932-5987 aroberts@saint-lukes.org
Contact: Sheila Erwin, RN 816-932-7996 serwin@saint-lukes.org
Principal Investigator: Adnan Chhatriwalla, MD
Sub-Investigator: Keith Allen, MD
Sub-Investigator: David Skolnick, MD
Sub-Investigator: V. Erick Thompson, MD
Sub-Investigator: Bethany Austin, MD
Sub-Investigator: John Saxon, MD
Sub-Investigator: Kenneth Huber, MD
Sub-Investigator: Anthony Magalski, MD
Sub-Investigator: Michael Main, MD
Sub-Investigator: A. Michael Borkon, MD
Sub-Investigator: J. Russell Davis, MD
United States, New Jersey
Morristown Medical Center	Recruiting
Morristown, New Jersey, United States, 07960
Contact: Catherine Van Zile, RN 973-971-5951 Catherine.vanzile@atlantichealth.org
Principal Investigator: Robert Kipperman, MD
Sub-Investigator: Philippe Genereux, MD
Sub-Investigator: John Brown, MD
Rutgers-RWJMS	Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Jennifer Pineda-Salazar 732-235-9125 JP1838@rwjms.rutgers.edu
Contact: Meghan Smith 732-235-9228 meghan.smith@rutgers.edu
Principal Investigator: Mark Russo, MD
Sub-Investigator: Leonard Lee, MD
Sub-Investigator: Abdul Hakeem, MD
Sub-Investigator: Bruce Haik, MD
Sub-Investigator: Deepa Iyer, MD
Sub-Investigator: Sabha Bhatti, MD
United States, New York
Albany Medical College	Recruiting
Albany, New York, United States, 12208
Contact: Nancy Giebelhaus 518-262-5018 GiebelN@amc.edu
Contact: Amanda O'Malley 518-262-6077 Aomalley@capitalcardiology.com
Principal Investigator: Chanderdeep Singh, MD
Sub-Investigator: Augustin Delago, MD
Sub-Investigator: Mohammad El-Hajjar, MD
Sub-Investigator: Eugene Pashkovetsky, MD
Sub-Investigator: Lance Sullenberger, MD
Montefiore Medical Center	Recruiting
Bronx, New York, United States, 10461
Contact: Zeynep Alimchandani 718-920-5633 Zalimchand@montefiore.org
Contact: Veronica Day 718-904-2172 Vday@montefiore.org
Principal Investigator: Mohammed Latib, MD
Sub-Investigator: Mei Chau, MD
Sub-Investigator: Courtney Lucyk, RN
Sub-Investigator: Mary Meneses, RN
Sub-Investigator: Sandhya Murthy, MD
Sub-Investigator: Patricia Chevez, MD
State University of New York at Buffalo	Recruiting
Buffalo, New York, United States, 14203
Contact: Courtney Bishop 716-888-4839 Cabishop@buffalo.edu
Contact: Robin Stein, RN 716-888-4859 rmstein3@buffalo.edu
Principal Investigator: Vijay Iyer, MD
Sub-Investigator: Stanley Fernandez, MD
NYU Winthrop Hospital	Recruiting
Mineola, New York, United States, 11501
Contact: Melissa Batteria 516-663-9738 Melissa.Batteria@nyulangone.org
Contact: Marina Licata 516-663-9738 Marina.licata@nyulangone.org
Principal Investigator: Richard Schwartz, DO
Sub-Investigator: Khaled Salhab, MD
Sub-Investigator: Nicholas Raio, MD
Sub-Investigator: Daniel Donohue, MD
Sub-Investigator: George Gubernikoff, MD
Sub-Investigator: Richard Jacaruso, MD
NYU Langone Health	Recruiting
New York, New York, United States, 10016
Contact: Illya Pushkar 212-263-4188 illyapushkar@nyulangone.org
Contact: Danielle Sin 212-263-4180 danielle.sin@nyulangone.org
Principal Investigator: Mathew Williams, MD
Sub-Investigator: Cezar Staniloae, MD
Sub-Investigator: Homam Ibrahim, MD
Columbia University Medical Center/New York Presbyterian Hospital	Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton 347-514-3366 Keb2114@cumc.columbia.edu
Contact: Lauren Privitera 347-271-0901 Lp2183@cumc.columbia.edu
Principal Investigator: Susheel Kodali
Sub-Investigator: Tamim Nazif
Sub-Investigator: Isaac George
Sub-Investigator: Vinayak Bapat
Sub-Investigator: Torsten Vahl
Sub-Investigator: Vivian Ng
Sub-Investigator: Rebecca Hahn
Sub-Investigator: Amisha Patel
Sub-Investigator: Omar Khalique
Lenox Hill Hospital and Manhasset, Northwell Health	Recruiting
New York, New York, United States, 10075
Contact: Amelia Ng, RN 212-434-4916 Ang13@northwell.edu
Contact: Efstathia (Effe) Mihelis, PA-C, MBA 212-434-6614 emihelis@northwell.edu
Principal Investigator: Chad A Kliger, MD
Sub-Investigator: S. Jacob Scheinerman, MD
Sub-Investigator: Nirav C Patel, MD
Sub-Investigator: Luigi Pirelli, MD
Sub-Investigator: Itzhak Kronzon, MD
Sub-Investigator: Prihi Mehla, MD
St. Francis Hospital	Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago, RN 516-562-6763 Lyn.santiago@chsli.org
Contact: Linda Bongiovanni, RN 516-562-6790 Linda.bongiovanni@chsli.org
Principal Investigator: George A Petrossian, MD
Principal Investigator: Newell B Robinson, MD
Sub-Investigator: Andrew D Berke, MD
Sub-Investigator: William Chung, MD
Sub-Investigator: Lin Wang, MD
United States, North Carolina
Atrium Health/Sanger Heart & Vascular Institute	Active, not recruiting
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Christ Hospital	Recruiting
Cincinnati, Ohio, United States, 45219-2906
Contact: Marien Bryson 513-585-1777 marien.bryson@thechristhospital.com
Contact: Deborah Garza 513-585-1777 deborah.garza@thechristhospital.com
Principal Investigator: Ian Sarembock, MD
Principal Investigator: Mario Castillo-Sang, MD
Sub-Investigator: Joseph Choo, MD
Sub-Investigator: Sayta Shreenivas, MD
Sub-Investigator: Terri Stewart-Dehner, MD
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Lydia Sweeney 216-444-7754 sweenel@ccf.org
Contact: Nora Brown 216-445-8063 Brownn2@ccf.org
Principal Investigator: Samir Kapadia, MD
Sub-Investigator: Leonard Rodriguez, MD
Sub-Investigator: James Yun, MD
Sub-Investigator: Rhonda Miyasaka, MD
Sub-Investigator: Serge Harb, MD
Sub-Investigator: Amar Krishnaswamy, MD
The Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Roderick Liptrot 614-292-0858 roderick.liptrot@osumc.edu
Contact: Annie Kellum 614-366-8848 annie.kellum@osu.edu
Principal Investigator: Konstantinos Boudoulas, MD
Sub-Investigator: Scott Lily, MD
Sub-Investigator: Gregory Rushing, MD
Sub-Investigator: David Orsinelli, MD
Sub-Investigator: Thura Harfi, MD
Sub-Investigator: Susan O'Neil, MD
OhioHealth Research Institute	Recruiting
Columbus, Ohio, United States, 43214
Contact: Katy Monnin 614-566-1250 Katy.Monnin@Ohiohealth.com
Contact: Wachy Vongchucherd 614-788-3861 Wachy.Vongchucherd@ohiohealth.com
Principal Investigator: Carlos Sanchez, MD
Principal Investigator: Nathan Howard Kander, MD
Sub-Investigator: Arash Arshi, MD
Sub-Investigator: Steven Yakubov, MD
Sub-Investigator: Steven Duff, MD
Sub-Investigator: Naveen Saha, MD
Sub-Investigator: David Richards, MD
United States, Oklahoma
Oklahoma Heart Institute	Recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Donnell Smith 918-579-4939 Donnell.smith@oklahomaheart.com
Contact: Angela Sconyers 918-579-4924
Principal Investigator: Kamran Muhammad, MD
Sub-Investigator: Wayne Leimbach, MD
Sub-Investigator: Hoda Butrous, MD
Sub-Investigator: John Tulloch, MD
Sub-Investigator: Michael Phillips, MD
Sub-Investigator: Georgianne Tokarchik, APRN-CNS
United States, Oregon
Providence St. Vincent Medical Center	Recruiting
Portland, Oregon, United States, 97225
Contact: Sarah Grant 503-216-7370 Sarah.grant@providence.org
Contact: Gretchen Sminkey 503-216-7162 Gretchen.sminkey@providence.org
Principal Investigator: Robert W Hodson, MD
Sub-Investigator: Eric Kirker, MD
Sub-Investigator: Ethan Korngold, MD
Sub-Investigator: Brandon Jones, MD
Sub-Investigator: Geoff Wilson, MD
Sub-Investigator: Craig Walsh, MD
Oregon Health & Science University	Recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Fishbein 503-494-9114 fishbein@ohsu.edu
Principal Investigator: Firas Zahr, MD
Sub-Investigator: Howard Song, MD, PhD
Sub-Investigator: Scott Chadderdon, MD
Sub-Investigator: Kate Rajotte, PA-C
Sub-Investigator: Kellie Graham, NP
United States, Pennsylvania
Hospital of the University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica Steigerwalt 215-615-3265 Jessica.Steigerwalt@uphs.upenn.edu
Contact: Eva Laverty-Wilson 215-615-3265 Eva.Laverty-Wilson@uphs.upenn.edu
Principal Investigator: Howard Herrmann, MD
Principal Investigator: Wilson Szeto, MD
Allegheny General Hospital	Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Stephanie Vehec 412-359-6908 Stephanie.Vehec@ahn.org
Contact: Tracy Spirk 412-359-4025 Tracy.Spirk@ahn.org
Principal Investigator: Walter McGregor, MD
Sub-Investigator: Mithun Chakravarthy, MD
Sub-Investigator: David Lasorda, MD
Sub-Investigator: Stephen Bailey, MD
Sub-Investigator: Victor Farah, MD
Sub-Investigator: Matthew Lander, MD
Sub-Investigator: Rachel Hughes-Doichev, MD
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg	Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Courtney Rodgers, RN 717-639-6410 clrodgers@pinnaclehealth.org
Contact: Brittany Fehr 717-503-5671 bfehr@pinnaclehealth.org
Principal Investigator: Mubashir Mumtaz, MD
Sub-Investigator: Hemal Gada, MD
Sub-Investigator: Amit Vora, MD
Sub-Investigator: David Loran, MD
Sub-Investigator: Nikhil Jaik, MD
Sub-Investigator: Atizazul Mansoor, MD
Sub-Investigator: Roberto Hodara, MD
Lankenau Medical Center	Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Jennifer Jordan 484-476-8580 jordanje@mlhs.org
Contact 484-476-8514 herrings@mlhs.org
Principal Investigator: Scott Goldman, MD
Sub-Investigator: William Gray, MD
Sub-Investigator: Roberto Rodriguez, MD
Sub-Investigator: Paul Coady, MD
Sub-Investigator: Sandra Abramson, MD
Sub-Investigator: Katie Hawthorne, MD
United States, Tennessee
Centennial Medical Center	Recruiting
Nashville, Tennessee, United States, 37203
Contact: Abdullah Shamsuddin 615-329-7274 Abdullah.shamsuddin@saracannon.com
Contact: Hallie Hank 615-329-6856 Hallie.hank@hcahealthcare.com
Principal Investigator: John Riddick, MD
Sub-Investigator: Sreekumar Subramanian, MD
Sub-Investigator: Thomas McRae, MD
Sub-Investigator: Thomas Johnston, MD
Sub-Investigator: David Huneycutt, MD
Sub-Investigator: Samuel Horr, MD
Sub-Investigator: Andrew Goodman, MD
Sub-Investigator: Parag Patel, MD
Saint Thomas Heart at Saint Thomas West	Recruiting
Nashville, Tennessee, United States, 37205
Contact: Amelia Drennan 615-222-3815 Amelia.drennan@ascension.org
Contact: Hollie Horton 615-222-3865 Hollie.horton@ascension.org
Principal Investigator: Michael A Morse, MD
Sub-Investigator: Evelio Rodriguez, MD
Sub-Investigator: Wilson E Kemp, MD
Sub-Investigator: John B Biglane, MD
Sub-Investigator: Andrew Zurick, MD
Sub-Investigator: Sasan Raissi, MD
United States, Texas
Medical City Dallas	Recruiting
Dallas, Texas, United States, 75230
Contact: Mona Hedra 972-566-3140 Mona.hedra@scresearch.net
Contact: Brandon Prince 972-566-2637 brandon.prince2@scresearch.net
Principal Investigator: Bruce Bowers, MD
Principal Investigator: Todd Dewey, MD
HCA Houston Healthcare Medical Center	Recruiting
Houston, Texas, United States, 77004
Contact: Joan Morrison 832-633-5463 Joan.Morrison@HCAhealthcare.com
Contact: Faisal Cheema 917-499-5115 Faisal.Cheema@HCAhealthcare.com
Principal Investigator: Pranav Loyalka, MD
Sub-Investigator: Abdul Hannan-Chaugle, MD
Sub-Investigator: Carlos Encarnacion, MD
Sub-Investigator: Eyal Porat, MD
Sub-Investigator: Stephanie Coulter, MD
Sub-Investigator: Amir Gahremanpour, MD
Houston Methodist Hospital	Recruiting
Houston, Texas, United States, 77030
Contact: Lisa Green, RN 713-441-3629 LMGreen@houstonmethodist.org
Contact: LaShawna Green, RN 713-441-6548 LaGreen@houstonmethodist.org
Principal Investigator: Neal Kleiman, MD
Principal Investigator: Michael Reardon, MD
Sub-Investigator: Nadeen Faza, MD
Sub-Investigator: Apurva Patel, MD
Sub-Investigator: Manuel Reyes, MD
Sub-Investigator: Marvin Atkins, MD
The University of Texas Health Science Center at Houston	Recruiting
Houston, Texas, United States, 77030
Contact: Elena Viverette 713-500-5214 Elena.a.viverette@uth.tmc.edu
Contact: Elizabeth Turrentine 713-500-5683 Elizabeth.p.turrentine@Uth.tmc.edu
Principal Investigator: Abhijeet Dhoble, MD
Sub-Investigator: Richard W Smalling, MD, PhD
Sub-Investigator: Enrique Garcia-Sayan, MD
Sub-Investigator: Tom C Nguyen, MD
Sub-Investigator: Anthony Estrera, MD
The Heart Hospital Baylor Plano	Recruiting
Plano, Texas, United States, 75093
Contact: Brittany Zingler 469-814-4737 brittany.zingler@bswhealth.org
Contact: Necole Kell 469-814-4737 necole.kell@bswhealth.org
Principal Investigator: Robert L Smith, MD
Sub-Investigator: Molly Szerlip, MD
Sub-Investigator: Paul Grayburn, MD
Sub-Investigator: Timothy George, MD
Sub-Investigator: Sameh Sayfo, MD
United States, Utah
Intermountain Medical Center	Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Hannah Bezdjian 801-507-4925 Hannah.Bezdjian@imail.org
Contact: Adrianna Robison 801-507-4764 Adrianna.Robison@imail.org
Principal Investigator: Brian K Whisenant, MD
Sub-Investigator: James Harkness, MD
Sub-Investigator: Kent Jones, MD
Sub-Investigator: Stephen Clayson, MD
United States, Virginia
University of Virginia	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes, RN, CCRC 434-982-1058 lgs2m@virginia.edu
Contact: Jessica Morris, CRC 434-982-1058 jlm6u@hscmail.mcc.virginia.edu
Principal Investigator: David Scott Lim, MD
Sub-Investigator: Gorav Ailawadi, MD
Sentara Norfolk General Hospital	Recruiting
Norfolk, Virginia, United States, 23507
Contact: Chelle Zulick 757-388-5480 SCRI@sentara.com
Contact: Camille Richards 757-388-5480 SCRI@sentara.com
Principal Investigator: Paul Mahoney, MD
Sub-Investigator: David Adler, MD
Sub-Investigator: Joseph Newton, MD
United States, Washington
Swedish Medical Center	Recruiting
Seattle, Washington, United States, 98122
Contact: Michelle Poitevin 206-320-2385 Michelle.Poitevin@swedish.org
Contact: Andrea Drouhard 206-215-3982 Andrea.Drouhard@swedish.org
Principal Investigator: Ming Zhang, MD
Sub-Investigator: Sameer Gafoor, MD
Sub-Investigator: John Petersen, MD
Sub-Investigator: Oana Petrescu, MD
Sub-Investigator: Patrick Ryan, MD
Sub-Investigator: Eric Lehr, MD
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Katherine Jordan 206-616-6768 Jordank1@uw.edu
Contact: Claire Schwaegler 206-685-4680 Claire13@cardiology.washington.edu
Principal Investigator: Mark Reisman, MD
Sub-Investigator: Gabriel Aldea, MD
Sub-Investigator: Georg Mackensen, MD
Canada, British Columbia
St. Pauls Hospital	Active, not recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Ontario
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Alana Harrington 416-864-6060 ext 49003 Alana.Harrinton@Unityhealth.to
Contact: Ivana Kandic 416-864-6060 ext 49003 Ivana.Kandic@unityhealth.to
Principal Investigator: Neil Fam, MD
Sub-Investigator: Gordon Moe, MD
Sub-Investigator: Geraldine Ong, MD
Sub-Investigator: Kim Connelly, MD
Sub-Investigator: Jeremy Edwards, MD
Sub-Investigator: Askhay Bagai, MD
Sub-Investigator: Mark Peterson, MD
Canada
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval	Recruiting
Québec, Canada, G1V 4G5
Contact: Shirley Baril 418-656-8711 ext 4129 Shirley.baril@criucpq.ulaval.ca
Contact: Dominique LaChance 418-656-8711 ext 3055 Dominique.Lachance@criucpq.ulaval.ca
Principal Investigator: Josep Rodés-Cabau, MD
Sub-Investigator: Kim O'Connor, MD
Sub-Investigator: Jonathan Beaudoin, MD
Sub-Investigator: Mathieu Bernier, MD
Sub-Investigator: Francois Dagenais, MD
Sub-Investigator: Eric Dumont, MD
Sub-Investigator: Jean-Michel Paradis, MD
Sub-Investigator: Alberto Alperi-Garcia, MD
Sub-Investigator: Erwan Salaun, MD
Germany
Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum	Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Elisabeth Winkelmann +49(0) 5731/97-3758 ewinkelmann@hdz-nrw.de
Contact: Kerstin Freese +49(0) 5731-973397 kfreese@hdz-nrw.de
Principal Investigator: Volker Rudolph, MD
Sub-Investigator: Kai Friedrichs, MD
Sub-Investigator: Werner Scholtz, MD
Sub-Investigator: Tanja Rudolph, MD
Sub-Investigator: Fabian Roder, MD
Sub-Investigator: Sabine Bleiziffer, MD
Sub-Investigator: Rene Schramm, MD
Sub-Investigator: Kavous Hakim-Meibodi, MD
Sub-Investigator: Tomasz Gilis-Januszewski, MD
Sub-Investigator: Nobuyuki Furukawa, MD
Sub-Investigator: Muhammed Gercek, MD
Sub-Investigator: Lasha Gortamashuili, MD
Sub-Investigator: Arseniy Goncharov, MD
Sub-Investigator: Max Potratz, MD
Herzzentrum Universitätsklinik Dresden	Recruiting
Dresden, Germany, 01307
Contact: Jennifer Hommel (Adam) +49 351 450 25237 jennifer.hommel@tu-dresden.de
Contact: Marion Mai +49 351 450 25 261 marion.mai@tu-dresden.de
Principal Investigator: Axel Linke, MD
Sub-Investigator: Stephen Haussig, MD
Sub-Investigator: Christian Pflücke, MD
Sub-Investigator: Norman Mangner, MD
Sub-Investigator: Felix Heidrich, MD
Sub-Investigator: Krunoslav M Sveric, MD
Sub-Investigator: Goerg Ende, MD
Sub-Investigator: Ephraim Winzer, MD
Sub-Investigator: Utz Kappert, MD
Sub-Investigator: Konstantinos Alexiou, MD
Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum	Recruiting
Essen, Germany, 45147
Contact: Alexander Weise +49 201 723 84833 alexander.wiese@uk-essen.de
Contact: Olga Babinets +49 201 723 84834 olga.babinets@uk-essen.de
Principal Investigator: Peter Ludike, MD
Sub-Investigator: Tienush Rassaf, MD
Sub-Investigator: Alexander Weymann, MD
Sub-Investigator: Alexander Lind, MD
Sub-Investigator: Bastian Schmack, MD
Sub-Investigator: Matthias Riebisch, MD
Sub-Investigator: Stefanie Hendricks, MD
Sub-Investigator: Lars Michel, MD
Sub-Investigator: Amir-Abbas Mahabadi, MD
Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie	Recruiting
Gießen, Germany, 35392
Contact: Christiane Kelm +49 641 985 57941 Christiane.Kelm@innere.med.uni-giessen.de
Contact: Anne Staubitz +49 641 985 57941 Anne.Staubitz@innere.med.uni-giessen.de
Principal Investigator: Holger Nef, MD
Sub-Investigator: Niklas Boeder, MD
Sub-Investigator: Matthias Bayer, MD
Sub-Investigator: Birgit Abmus, MD
Sub-Investigator: Peter Roth, MD
Sub-Investigator: Annika Klar, MD
Sub-Investigator: Stanislav Keranov, MD
Sub-Investigator: Korinna Feldmann, MD
Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie	Recruiting
Hamburg, Germany, 20246
Contact: Kirsten Suhr +49 40-741056287 K.suhr@uke.de
Contact: Sonja Stolze +49 40 7410 53246 S.stolze@uke.de
Principal Investigator: Edith Lubos, MD
Sub-Investigator: Niklas Schofer, MD
Sub-Investigator: Daniel Kalbacher, MD
Sub-Investigator: Dorit Knappe, MD
Sub-Investigator: Lenard Conradi, MD
Sub-Investigator: Johannes Schirmer, MD
Sub-Investigator: Fabian J Brunner, MD
Sub-Investigator: Christoph Sinning, MD
Sub-Investigator: Peter Moritz-Becher, MD
Sub-Investigator: Peter Clemmensen, MD
Herzzentrum Leipzig Universitätsklinik für Kardiologie	Recruiting
Leipzig, Germany, 04289
Contact: Kai Trautmann +49 341 865 1591 Kai.Trautmann@leipzig-heart.de
Contact: Margit Büttner +49 341 865 1591 Margit.Buettner@leipzig-heart.de
Principal Investigator: Philipp Lurz, MD
Sub-Investigator: Thilo Noack, MD
Sub-Investigator: Philipp Kiefer, MD
Sub-Investigator: Christian Besler, MD
Sub-Investigator: Steffen Desch, MD
Sub-Investigator: Holger Thiele, MD
Sub-Investigator: Maximilian von Roeder, MD
Sub-Investigator: Marcus Sandri, MD
Sub-Investigator: Marion Zimmer, MD
Sub-Investigator: Christian Binner, MD
Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz	Recruiting
Mainz, Germany, 55131
Contact: Susanne Wüst +49 6131 172887 susanne.wuest@unimedizin-mainz.de
Contact: Saskia Goetze +49 6131 17-6279 saskia.goetze@unimedizin-mainz.de
Principal Investigator: Ralph von Bardeleben, MD
Sub-Investigator: Felix Kreidel, MD
Sub-Investigator: Alexander Tamm, MD
Sub-Investigator: Tobias Ruf, MD
Sub-Investigator: Andres Fernandez, MD
Sub-Investigator: Martin Geyer, MD
Sub-Investigator: Philip Wenzel, MD
Sub-Investigator: Markus Vosseler, MD
Sub-Investigator: Simon Distelmeier, MD
Sub-Investigator: Angela Kornberger, MD
Medizinische Klinik I LMU München Campus Grosshadern	Recruiting
München, Germany, 81377
Contact: Diana Roesler +49 89 4400 76084 diana.roesler@med.uni-muenchen.de
Contact: Stephanie Menner +49 89 4400 76075 stephanie.menner@med.uni-muenchen.de
Principal Investigator: Jörg Hausleiter, MD
Sub-Investigator: Michael Näbauer, MD
Sub-Investigator: Daniel Braun, MD
Sub-Investigator: Mathias Orban, MD
Sub-Investigator: Thomas Stocker, MD
Sub-Investigator: Erik Bagaev, MD
Sub-Investigator: Sebastian Sadoni, MD

Sponsors and Collaborators

Edwards Lifesciences

Investigators

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Principal Investigator:	Scott Lim, MD	University of Virginia
Principal Investigator:	Robert Smith, MD	The Heart Hospital Baylor Plano
Principal Investigator:	Linda Gillam, MD	Morristown Medical Center
Principal Investigator:	Vinod Thourani, MD	Piedmont Healthcare
Principal Investigator:	Paul Grayburn, MD	The Heart Hospital Baylor Plano
Principal Investigator:	Brian K Whisenant, MD	Intermountain Medical Center

More Information

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Responsible Party:	Edwards Lifesciences
ClinicalTrials.gov Identifier:	NCT03706833
Other Study ID Numbers:	2018-07
First Posted:	October 16, 2018 Key Record Dates
Last Update Posted:	December 19, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Device Product Not Approved or Cleared by U.S. FDA:	Yes

Additional relevant MeSH terms:

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Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases

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