This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

Tendyne TranscatheterClinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Sponsor:

Abbott Medical Devices

Code:

NCT03433274

Conditions

Mitral Regurgitation

Mitral Insufficiency

Mitral Valve Insufficiency

Cardiovascular Diseases

Valve Disease, Heart

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tendyne Mitral Valve System

MitraClip System

Study Details

Brief summary:

Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Conditions

Mitral Regurgitation

Mitral Insufficiency

Mitral Valve Insufficiency

Cardiovascular Diseases

Valve Disease, Heart

Study ID

NCT03433274

Start date

Jun 15, 2018

Status verified date

Aug, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

May 15, 2024

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
The local site heart team determines that the subject has been adequately treated per applicable standards
Not a member of a vulnerable population

Exclusion Criteria:

Mitral valvular vegetation or mass
Left ventricular ejection fraction < 25%
Left ventricular end diastolic diameter > 7.0 cm
Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
Aortic valve disease requiring surgery or transcatheter intervention
Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
Subject undergoing hemodialysis due to chronic renal failure
Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

Study Design

Enrollment

958 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Randomized Cohort - Treatment Group

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

active comparator: Randomized Cohort - Control Group

Treatment of mitral regurgitation within commercially approved MitraClip system indications

experimental: Non-repairable Cohort

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

experimental: Severe Mitral Annular Calcification (MAC) Cohort

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System

experimental: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort

Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort

Interventions

Tendyne Mitral Valve System

Mitral valve replacement

MitraClip System

Percutaneous mitral valve repair using the MitraClip system.

Primary outcome measure

Randomized Cohort [ Time Frame: 1 year ]
Non-repairable Cohort [ Time Frame: 1 year ]
Severe Mitral Annular Calcification (MAC) Cohort [ Time Frame: 1 year ]
Severe MAC Continued Access Protocol (MAC CAP) Cohort [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kayla Dellefratte

+1 (669)214-9748 SUMMIT.Trial@abbott.com

Leslie Ornelas

+1 (602)692-5047 leslie.ornelas@abbott.com

Locations

UAB University Hospital

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Kathy Phillips

205-975-9426 kcphillips@uabmc.edu

Principal Investigator:

Mustafa Ahmed, M.D.

Banner-University Medical Center

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Mathew Freeman

623-293-3945 Mathew.Freeman@bannerhealth.com

Principal Investigator:

Philip Gideon, M.D.

HonorHealth Scottsdale Shea Medical Center

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Alisha Vandriel

480-323-1046 avandriel@honorhealth.com

Principal Investigator:

David Rizik, M.D.

Baptist Health Medical Center

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Richard Bailey

501-202-4421 richard.bailey@baptist-health.org

Principal Investigator:

Bassam Shukrallah, MD

University of California - Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Kimberley Book

916-734-5639 kabook@ucdavis.edu

Principal Investigator:

Jason Rogers, M.D.

San Diego Cardiac Center

Recruiting

San Diego, California, United States, 92123

Contacts

Emma Burkhalter

eburkhalter@sdcardiac.com

Principal Investigator:

Raghava Gollapudi, M.D.

Stanford Health Care

Recruiting

Stanford, California, United States, 94305

Contacts

Joshua Lee

650-498-1129 joshmlee@stanford.edu

Principal Investigator:

Rahul Sharma, M.D.

Los Robles Hospital and Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Mane Arabyan

805-796-3746 Mane.arabyan@hcahealthcare.com

Principal Investigator:

Gregory Fontana, M.D.

Morton Plant Hospital

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Sue Fisher

727-462-7574 Susan.Fisher1@baycare.org

Principal Investigator:

Joshua Rovin, M.D.

Shands at the University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Jessica Cobb

352-273-7837 jessica.cobb@surgery.ufl.edu

Principal Investigator:

Thomas Beaver, M.D.

Tallahassee Research Institute

Recruiting

Tallahassee, Florida, United States, 32308

Contacts

Dana Porter

850-431-5024 Dana.Porter@tmh.org

Principal Investigator:

Thomas Noel, M.D.

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Maria Mejia-Gomez

954-659-5888 mejiagm@ccf.org

Principal Investigator:

Samir Kapadia, M.D.

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Brittney Truss

404-695-7023 Brittney.Truss@piedmont.org

Principal Investigator:

Vinod Thourani, M.D.

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Maria Kaner

404-375-5751 maria.kaner@emory.edu

Principal Investigator:

Vasilis Babaliaros, M.D.

Wellstar Kennestone Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Jennifer Cuvo

470-793-4063 Jennifer.Cuvo@wellstar.org

Principal Investigator:

Amar Patel, MD

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Colleen Gallagher

708-684-9699 colleen.gallagher@aah.org

Principal Investigator:

Ravi Ramana, M.D.

St. Vincent Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Hannah Willard

317-583-6115 hannah.jenkins1@ascension.org

Principal Investigator:

Sina Moainie, M.D.

Cardiovascular Research Institute of Kansas

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Meredith Thunberg

316-213-8001 meredith.thunberg@ascension.org

Principal Investigator:

Bassem Chehab, M.D.

MedStar Health Research Institute

Recruiting

Balitmore, Maryland, United States, 21218

Contacts

Keith Moyer

443-278-9170 keith.t.moyer@medstar.net

Principal Investigator:

Brian Bethea, M.D.

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Allison Schley

734-232-4319 schleya@med.umich.edu

Principal Investigator:

Matthew Romano, M.D.

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Danielle Holmes

313-916-3559 dholmes7@hfhs.org

Principal Investigator:

Tiberio Frisoli, M.D.

Abbott Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jennifer Nguyen

612-863-9291 jennifer.nguyen@allina.com

Principal Investigator:

Paul Sorajja, M.D.

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Carl Griffin II

507-255-5690 GriffinII.carl@mayo.edu

Principal Investigator:

Mayra Guerrero, MD

St. Luke's Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Peggy Owen

marowen1@saint-lukes.org

Principal Investigator:

Keith Allen, M.D.

The International Heart Institute of Montana

Recruiting

Missoula, Montana, United States, 59802

Contacts

Christina Michael

406-327-1693 Christina.Michael@providence.org

Principal Investigator:

James Maddux, M.D.

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Manuel Castillo

551-996-2136 Manuel.Castillo@hmhn.org

Principal Investigator:

Ryan Kaple, M.D.

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Christopher Stradford

732-235-7231 css165@rwjms.rutgers.edu

Principal Investigator:

Mark Russo, M.D.

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Patricia Policastro

973-926-8451 Patricia.Policastro@rwjbh.org

Principal Investigator:

Arash Salemi, M.D.

Albany Medical College at Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Alan Dagistino

518-262-8264 dagista@amc.edu

Principal Investigator:

Sanjay Samy, M.D.

South Shore University Hospital

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Samantha Annunziato

516-562-2653 sannunziato@northwell.edu

Principal Investigator:

Robert Kalimi, M.D.

Buffalo General Hospital

Recruiting

Buffalo, New York, United States, 14203

Contacts

Courtney Bishop

716-888-4859 cabishop@buffalo.edu

Principal Investigator:

Vijay Iyer, M.D.

New York Presbyterian Hospital/ Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Marshagay Rodriques

212-746-5594 mar4028@med.cornell.edu

Principal Investigator:

Stephanie Mick, M.D.

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Contacts

Ameerah Ali

aali35@northwell.edu

Principal Investigator:

Robert Kalimi, M.D.

Mission Health & Hospitals

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Christina Riggsbee

828-213-5632 christina.riggsbee@HCAHealthcare.com

Principal Investigator:

Mark Groh, M.D.

Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Montana Bright

montana.bright@atriumhealth.org

Principal Investigator:

Michael Rinaldi, M.D.

Novant Health Heart and Vascular Research Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Amy Clontz

aclontz@novanthealth.org

Principal Investigator:

Oluseun Alli, M.D.

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Elias Shamieh

513-558-3016 shamiees@ucmail.uc.edu

Principal Investigator:

Imran Arif, MD

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Theresa Sanford

216-444-6452 sanfort2@ccf.org

Principal Investigator:

Samir Kapadia, M.D.

Oklahoma Heart Institute at Utica

Recruiting

Tulsa, Oklahoma, United States, 74104

Contacts

Loyce Keeton

loyce.chintsanyakeeton@hillcrest.com

Principal Investigator:

Kamran Muhammad, M.D.

Providence Heart & Vascular Institute

Recruiting

Portland, Oregon, United States, 97225

Contacts

Sarah Jackson

503-216-7370 sarah.jackson3@providence.org

Principal Investigator:

Brandon Jones, M.D.

Allegheny General Hospital - ASRI

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Tracy Spirk

412-359-4025 Tracy.Spirk@ahn.org

Principal Investigator:

Walter McGregor, M.D.

UPMC Shadyside

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Melissa Sanders Linger

412-623-2809 sanderslingerm@upmc.edu

Principal Investigator:

Anson Smith, M.D.

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Stephanie Schorr

843-792-7678 schorr@musc.edu

Principal Investigator:

Marc Katz, M.D.

Baptist Memorial Hospital

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Kari Fondren

901-271-4064 kfond@sterncardio.com

Principal Investigator:

Basil Paulus, M.D.

Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Lauren Bozarth

615-982-2491 Lauren.Bozarth2@HCAhealthcare.com

Principal Investigator:

Sreekumar Subramanian, M.D.

St. Thomas Hospital

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Nikole Gasaway

615-222-3227 kolie.gasaway@ascension.org

Principal Investigator:

Evelio Rodriguez, M.D.

Cardiothoracic & Vascular Surgeons

Recruiting

Austin, Texas, United States, 78756

Contacts

Casey Harrell

charrell@ctvstexas.com

Principal Investigator:

Faraz Kerendi, M.D.

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Amber Li

713-486-6846 amber.p.li@uth.tmc.edu

Principal Investigator:

Sukhdeep Basra, M.D.

University of Virginia Medical Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Tevin Jefferson

434-982-1058 MFU3QX@uvahealth.org

Principal Investigator:

John Saxon, M.D.

Swedish Medical Center - Heart & Vascular

Recruiting

Seattle, Washington, United States, 98122

Contacts

Tina Pratt

206-320-3919 Kristina.Pratt@swedish.org

Principal Investigator:

Sameer Gafoor, M.D.

West Virginia University Hospital

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Joshua Bombard

304-598-4000 josh.bombard@wvumedicine.org

Principal Investigator:

Vinay Badhwar, M.D.

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jan 31, 2025

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2025-01-31.