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

NCT03433274 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: CS0004-P
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 78

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 Plan (MAC CAP). Subjects in the Randomized cohort were 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 were 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) was 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 would 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 would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort. Subjects would 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; Cardiovascular Diseases; Valve Disease, Heart; Heart Valve Diseases; Functional Mitral Regurgitation; Degenerative Mitral Valve Disease; Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH)

  The primary endpoint for the Severe MAC cohort is freedom from all-cause mortality and heart failure hospitalization (HFH), evaluated against a performance goal of 43%.

  12 months post index procedure

Secondary Outcomes (4)

• Percentage of Participants With Freedom From Mitral Regurgitation (MR) Severity > 1

  At 1 month post index procedure

• Change in KCCQ Overall Score

  From Baseline at 12 Months

• Change in Percentage of Participants With NYHA Class I & II

  Change from Baseline at 12 Months

• Change in Six Minute Walk Test

  From Baseline at 12 Months

Study Arms (5)

Randomized Cohort - Treatment Group

EXPERIMENTAL

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Device: Tendyne Mitral Valve System

Randomized Cohort - Control Group

ACTIVE COMPARATOR

Treatment of mitral regurgitation within commercially approved MitraClip system indications

Device: MitraClip System

Non-repairable Cohort

EXPERIMENTAL

Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System

Device: Tendyne Mitral Valve System

Severe Mitral Annular Calcification (MAC) Cohort

EXPERIMENTAL

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

Device: Tendyne Mitral Valve System

Severe Mitral Annular Calcification Continued Access Plan (MAC CAP) Cohort

EXPERIMENTAL

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

Device: Tendyne Mitral Valve System

Interventions

MitraClip System DEVICE

Percutaneous mitral valve repair using the MitraClip system.

Randomized Cohort - Control Group

Tendyne Mitral Valve System DEVICE

Mitral valve replacement

Non-repairable Cohort; Randomized Cohort - Treatment Group; Severe Mitral Annular Calcification (MAC) Cohort; Severe Mitral Annular Calcification Continued Access Plan (MAC CAP) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic, moderate-to-severe or severe mitral regurgitation (MR ≥ Grade III per American Society of Echocardiography criteria), or severe mitral annular calcification (MAC), where a transcatheter therapy is deemed more appropriate than open surgery by the local site heart team.
• Note: MR and MS severity must be determined by assessment of a qualifying transesophageal echocardiogram (TEE) and transthoracic echocardiogram (TTE), obtained within 120 days prior to subject consent, and must be confirmed by the Echocardiography Core Laboratory.
• Note: Patients with severe MAC must have symptomatic mitral valve disease associated with MR≥ Grade III, or severe mitral stenosis (MS), or both moderate MR and moderate MS as assessed by the Echocardiography Core Laboratory.
• 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 for coronary artery disease (e.g., revascularization), left ventricular dysfunction (e.g., cardiac resynchronization therapy) and heart failure (e.g., GDMT). The SEC must concur that the subject has been adequately treated.
• The local site heart team and the SEC concur on the intended study cohort for the subject.
• Randomized cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is suitable for TEER and are within approved Mitra Clip indications, which must be confirmed by experienced Mitra Clip operators within the SEC. Subjects with primary MR must be at prohibitive surgical risk, while subjects with secondary MR must be symptomatic despite maximally-tolerated guideline-directed medical therapy and meet the Mitra Clip Indications for Use.
• Non-repairable cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is not suitable for TEER with Mitra Clip or does not meet Mitra Clip indications, which must be confirmed by experienced Mitra Clip operators from the SEC.
• Severe MAC cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the degree of MAC renders the subject unsuitable for mitral valve surgery.
• Severe MAC CAP cohort: Eligibility for this cohort is identical to the original Severe MAC cohort.
• Age 18 years or older at time of consent.
• Subject has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group, complying with trial required testing, medications, and follow-up visits, and has provided written informed consent.

You may not qualify if:

• Mitral valvular vegetation or mass.
• Left Ventricle or Left Atrium thrombus.
• Chest condition that prevents transapical access.
• LVEF less than 25% assessed by the site based on a TTE obtained within 120 days prior to subject consent.
• Note: LVEF will be principally based on TTE and confirmed by the Echocardiography Core Laboratory.
• LVEDD \> 7.0 cm assessed by the site based on a TTE obtained within 120 days prior to subject consent.
• Note: A qualifying LVEDD must be confirmed by the Echocardiography Core Laboratory.
• Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material (e.g. valve repair or replacement, or Mitra Clip).
• Mitral pathoanatomy and LVOT anatomy deemed not suitable for Tendyne transcatheter mitral valve implantation.
• Aortic valve disease requiring surgery or transcatheter intervention.
• Tricuspid valve disease requiring surgery or transcatheter intervention.
• Severe tricuspid regurgitation or severe right ventricular dysfunction.
• Any surgical or interventional procedure within the period of 60 days prior to or planned procedure 60 days following subject registration.
• Implant or revision of CRT device within 90 days prior to intended subject registration.
• Myocardial infarction within 30 days prior to intended subject registration.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (78)

Baptist Medical Center Princeton

Birmingham, Alabama, 35211, United States

Location

UAB University Hospital

Birmingham, Alabama, 35233, United States

Location

Banner-University Medical Center

Phoenix, Arizona, 85006, United States

Location

Scottsdale Healthcare Shea

Scottsdale, Arizona, 85258, United States

Location

Baptist Health Medical Center

Little Rock, Arkansas, 72205, United States

Location

Fresno Heart Hospital

Fresno, California, 93720, United States

Location

University of Southern California University Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sutter Medical Center, Sacramento

Sacramento, California, 95816, United States

Location

University of California - Davis Medical Center

Sacramento, California, 95817, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Stanford Health Care

Stanford, California, 94305, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34208, United States

Location

BayCare Healthcare System - Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

HCA Florida North Florida Hospital

Gainesville, Florida, 32605, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Wellstar Kennestone Regional Medical Center

Marietta, Georgia, 30060, United States

Location

St. Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46260, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67226, United States

Location

MedStar Union Memorial Hospital

Balitmore, Maryland, 21218, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Adventist HealthCare White Oak Medical Center

Silver Spring, Maryland, 20904, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

St. Louis University Hospital

St Louis, Missouri, 63110, United States

Location

The International Heart Institute of Montana

Missoula, Montana, 59802, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Albany Medical College at Albany Medical Center

Albany, New York, 12208, United States

Location

South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

New York Presbyterian Hospital/Cornell University

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Mission Health

Asheville, North Carolina, 28801, United States

Location

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Novant Health Heart and Vascular Research Institute

Charlotte, North Carolina, 28204, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States

Location

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

Location

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

Location

St. David's Healthcare Office of Research

Austin, Texas, 78756, United States

Location

Baylor Scott & White Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

UTHealth Memorial Hermann

Houston, Texas, 77030, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Swedish Medical Center - Heart & Vascular

Seattle, Washington, 98122, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Institute)

Montreal, Quebec, H1T 1C8, Canada

Location

MUHC - The Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Cardiovascular Diseases; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Results Point of Contact

• Title: Kayla Dellefratte, Senior Manager Clinical Project Management
• Organization: Abbott

kayla.dellefratte@abbott.com

+16692149748

Study Officials

• Gorav Ailawadi, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Jason Rogers, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Kyle Brunner, PhD

  Abbott Structural Heart

  STUDY DIRECTOR

• Paul Sorajja, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

• Vinod Thourani, MD

  Piedmont Healthcare and the Marcus Heart Valve Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: June 15, 2018
• Primary Completion: April 29, 2024
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 12, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); US (73)