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Mitral RegurgitationSUMMITNCT03433274

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

A study testing Tendyne Mitral Valve System and MitraClip System in people with Mitral Regurgitation and Mitral Insufficiency, run by Abbott Medical Devices at 78 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tendyne Mitral Valve System and MitraClip System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
78 sitesin 2 countries
Study dates
15 Jun 2018to Jun 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 37Show fewer
  • 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.
  • Symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (e.g., active ischemia) requiring stenting or CABG.
  • CVA within 6 months prior to intended subject registration.
  • Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  • Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  • Hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis.
  • Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
  • History of endocarditis within 6 months of planned implant procedure.
  • Active systemic infection requiring antibiotic therapy.
  • Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation or antiplatelet therapy) that cannot be adequately managed medically.
  • Subjects in whom TEE is contraindicated or high risk.
  • Known hypersensitivity to nickel or titanium.
  • Subject is undergoing hemodialysis due to chronic renal failure.
  • Subject has pulmonary arterial hypertension (fixed PAS >70mmHg). Note: If PAS > 70mmHg, site must provide documentation PAS is not fixed in order to be eligible.
  • Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
  • Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months.
  • Modified Rankin Scale ≥ 4 disability.
  • Status 1 heart transplant or prior orthotopic heart transplantation.
  • Pregnant, lactating, or planning pregnancy during the clinical investigation follow-up period.
  • Note: Female subjects of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release).
  • Currently participating in an investigational drug or another device trial that has not reached its primary endpoint.
  • Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Trial locations and contacts

78 sites in 2 countries.

78 sites in 2 countries

United States73 sites

  • Albany Medical College at Albany Medical Center

    Albany, New York, 12208

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Mission Health

    Asheville, North Carolina, 28801

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • St. David's Healthcare Office of Research

    Austin, Texas, 78756

  • MedStar Union Memorial Hospital

    Balitmore, Maryland, 21218

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Northwell Health - South Shore University Hospital

    Bay Shore, New York, 11706

  • Baptist Medical Center Princeton

    Birmingham, Alabama, 35211

  • UAB University Hospital

    Birmingham, Alabama, 35233

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Novant Health Heart and Vascular Research Institute

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • BayCare Healthcare System - Morton Plant Hospital

    Clearwater, Florida, 33756

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor Scott & White The Heart Hospital - Dallas

    Dallas, Texas, 75226

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Fresno Heart Hospital

    Fresno, California, 93720

  • HCA Florida North Florida Hospital

    Gainesville, Florida, 32605

  • University of Florida

    Gainesville, Florida, 32610

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • UTHealth Memorial Hermann

    Houston, Texas, 77030

  • Ascension St. Vincent

    Indianapolis, Indiana, 46260

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Baptist Health Medical Center

    Little Rock, Arkansas, 72205

  • University of Southern California University Hospital

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Wellstar Kennestone Regional Medical Center

    Marietta, Georgia, 30060

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • The International Heart Institute of Montana

    Missoula, Montana, 59802

  • West Virginia University

    Morgantown, West Virginia, 26506

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901

  • New York Presbyterian Hospital/Cornell University

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Banner-University Medical Center

    Phoenix, Arizona, 85006

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212

  • UPMC Shadyside

    Pittsburgh, Pennsylvania, 15232

  • Providence Heart & Vascular Institute

    Portland, Oregon, 97225

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816

  • University of California - Davis Medical Center

    Sacramento, California, 95817

  • San Diego Cardiac Center

    San Diego, California, 92123

  • University of California at San Francisco

    San Francisco, California, 94143

  • Scottsdale Healthcare Shea

    Scottsdale, Arizona, 85258

  • Swedish Medical Center - Heart & Vascular

    Seattle, Washington, 98122

  • Adventist HealthCare White Oak Medical Center

    Silver Spring, Maryland, 20904

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62701

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • Stanford Health Care

    Stanford, California, 94305

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma, 74104

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Ascension Via Christi Hospitals Wichita

    Wichita, Kansas, 67226

Other trials in United States

Canada5 sites

  • Institut de Cardiologie de Montreal (Montreal Heart Institute)

    Montreal, Quebec, H1T 1C8

  • MUHC - The Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

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.

Read more

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.

Being tested
Tendyne Mitral Valve System, MitraClip System
Medical subject headings
Mitral Valve Insufficiency, Cardiovascular Diseases, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tendyne Mitral Valve SystemDevice

    Mitral valve replacement

  • MitraClip SystemDevice

    Percutaneous mitral valve repair using the MitraClip system.

Study groups in NCT03433274
Study groupRoleWhat they receive
Randomized Cohort - Treatment GroupExperimentalTreatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Receives: Device: Tendyne Mitral Valve System
Randomized Cohort - Control GroupActive comparatorTreatment of mitral regurgitation within commercially approved MitraClip system indications
Receives: Device: MitraClip System
Non-repairable CohortExperimentalTreatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Receives: Device: Tendyne Mitral Valve System
Severe Mitral Annular Calcification (MAC) CohortExperimentalTreatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
Receives: Device: Tendyne Mitral Valve System
Severe Mitral Annular Calcification Continued Access Plan (MAC CAP) CohortExperimentalTreatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort
Receives: Device: Tendyne Mitral Valve System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: 12 months post index procedure

Secondary outcomes (4)

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

    Freedom from MR > mild (1+) in severity at 1 month post index procedure among survivors.

    The null and alternative hypotheses are stated as:

    H0: PMR ≤ 1+ ≤ PPG H1: P MR ≤ 1+ > PPG where PMR ≤ 1+ is the proportion of subjects who have MR ≤ 1+ at 1 months post index procedure.

    Measured: At 1 month post index procedure

  2. Change in KCCQ Overall Score

    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item questionnaire developed to independently measure a patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. It includes questions on symptoms, physical limitations, social relationships, and emotional well-being. The KCCQ was administered by study personnel and completed by the subject. KCCQ scores range from 0-100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status.

    Measured: From Baseline at 12 Months

  3. Change in Percentage of Participants With NYHA Class I & II

    New York Heart Association Classification (NYHA Class): NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure:

    Class I Patients with cardiac disease but without resulting limitations of physical activity.

    Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

    Measured: Change from Baseline at 12 Months

  4. Change in Six Minute Walk Test

    To evaluate the benefit of the Tendyne device, the distance walked at 12 months as measured by the 6MWT was compared with that from baseline. The six-minute walk test is a simple cardiopulmonary functional testing modality. Its straightforward nature allows for a non-specific, integrated assessment of the many systems involved during physical activity. Specifically, its results can assist in ascertaining the degree of functional impairment and potentially lead to modifications in therapy for some cardiovascular and pulmonary conditions.

    Measured: From Baseline at 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2018
  2. Study start15 Jun 2018
  3. Primary completion29 Apr 2024
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03433274
Sponsor's protocol ID
CS0004-P
Acronym
SUMMIT
Status last verified
Dec 2025
First submitted
8 Feb 2018
Last updated
23 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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