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

February 27, 2026 updated by: Abbott Medical Devices

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Institut de Cardiologie de Montreal (Montreal Heart Institute)
      • Montreal, Quebec, Canada, H4A 3J1
        • MUHC - The Royal Victoria Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Baptist Medical Center Princeton
      • Birmingham, Alabama, United States, 35233
        • UAB University Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner-University Medical Center
      • Scottsdale, Arizona, United States, 85258
        • Scottsdale Healthcare Shea
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Medical Center
    • California
      • Fresno, California, United States, 93720
        • Fresno Heart Hospital
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California University Hospital
      • Sacramento, California, United States, 95817
        • University of California - Davis Medical Center
      • Sacramento, California, United States, 95816
        • Sutter Medical Center, Sacramento
      • San Diego, California, United States, 92123
        • San Diego Cardiac Center
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
      • Stanford, California, United States, 94305
        • Stanford Health Care
      • Thousand Oaks, California, United States, 91360
        • Los Robles Regional Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Florida
      • Bradenton, Florida, United States, 34208
        • Manatee Memorial Hospital
      • Clearwater, Florida, United States, 33756
        • BayCare Healthcare System - Morton Plant Hospital
      • Delray Beach, Florida, United States, 33484
        • Delray Medical Center
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Gainesville, Florida, United States, 32605
        • HCA Florida North Florida Hospital
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute
      • Marietta, Georgia, United States, 30060
        • Wellstar Kennestone Regional Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • St. Alphonsus Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
      • Springfield, Illinois, United States, 62701
        • Prairie Education & Research Cooperative
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Ascension St. Vincent
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Via Christi Regional Medical Center - St. Francis Campus
    • Maryland
      • Balitmore, Maryland, United States, 21218
        • MedStar Union Memorial Hospital
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Silver Spring, Maryland, United States, 20904
        • Adventist Healthcare White Oak Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • St Louis, Missouri, United States, 63110
        • St. Louis University Hospital
    • Montana
      • Missoula, Montana, United States, 59802
        • The International Heart Institute of Montana
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson University Hospital
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College at Albany Medical Center
      • Bay Shore, New York, United States, 11706
        • South Shore University Hospital
      • Buffalo, New York, United States, 14203
        • Buffalo General Medical Center
      • New York, New York, United States, 10075
        • Lenox Hill Hospital
      • New York, New York, United States, 10065
        • New York Presbyterian Hospital/Cornell University
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Health
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health - Carolinas Medical Center
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Heart and Vascular Research Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute at Utica
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence Heart & Vascular Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Shadyside
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital - ASRI
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital
      • Nashville, Tennessee, United States, 37203
        • TriStar Centennial Medical Center
      • Nashville, Tennessee, United States, 37205
        • Ascension Saint Thomas
    • Texas
      • Austin, Texas, United States, 78756
        • St. David's Healthcare Office of Research
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75226
        • Baylor Scott & White Heart and Vascular Hospital
      • Houston, Texas, United States, 77030
        • UTHealth Memorial Hermann
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center - Heart & Vascular
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.

  2. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory).
  3. 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.

  4. 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.

  5. Age 18 years or older at time of consent.
  6. 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.

Exclusion Criteria:

  1. Mitral valvular vegetation or mass.
  2. Left Ventricle or Left Atrium thrombus.
  3. Chest condition that prevents transapical access.

  4. 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.

  5. 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.

  6. Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material (e.g. valve repair or replacement, or Mitra Clip).
  7. Mitral pathoanatomy and LVOT anatomy deemed not suitable for Tendyne transcatheter mitral valve implantation.
  8. Aortic valve disease requiring surgery or transcatheter intervention.
  9. Tricuspid valve disease requiring surgery or transcatheter intervention.
  10. Severe tricuspid regurgitation or severe right ventricular dysfunction.
  11. Any surgical or interventional procedure within the period of 60 days prior to or planned procedure 60 days following subject registration.
  12. Implant or revision of CRT device within 90 days prior to intended subject registration.
  13. Myocardial infarction within 30 days prior to intended subject registration.
  14. Symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (e.g., active ischemia) requiring stenting or CABG.
  15. CVA within 6 months prior to intended subject registration.
  16. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
  17. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
  18. Hypertrophic or restrictive cardiomyopathy, or constrictive pericarditis.
  19. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated.
  20. History of endocarditis within 6 months of planned implant procedure.
  21. Active systemic infection requiring antibiotic therapy.
  22. 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.
  23. Subjects in whom TEE is contraindicated or high risk.
  24. Known hypersensitivity to nickel or titanium.
  25. Subject is undergoing hemodialysis due to chronic renal failure.
  26. 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.
  27. Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
  28. Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months.
  29. Modified Rankin Scale ≥ 4 disability.
  30. Status 1 heart transplant or prior orthotopic heart transplantation.

  31. 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).

  32. 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.

  33. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Randomized Cohort - Treatment Group
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Device: Tendyne Mitral Valve System
Mitral valve replacement
Active Comparator: Randomized Cohort - Control Group
Treatment of mitral regurgitation within commercially approved MitraClip system indications
Device: MitraClip System
Percutaneous mitral valve repair using the MitraClip system.
Experimental: Non-repairable Cohort
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Device: Tendyne Mitral Valve System
Mitral valve replacement
Experimental: Severe Mitral Annular Calcification (MAC) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
Device: Tendyne Mitral Valve System
Mitral valve replacement
Experimental: Severe Mitral Annular Calcification Continued Access Plan (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
Device: Tendyne Mitral Valve System
Mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH)
Time Frame: 12 months post index procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Freedom From Mitral Regurgitation (MR) Severity > 1
Time Frame: At 1 month post index procedure

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.
At 1 month post index procedure
Change in KCCQ Overall Score
Time Frame: From Baseline at 12 Months
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.
From Baseline at 12 Months
Change in Percentage of Participants With NYHA Class I & II
Time Frame: Change from Baseline at 12 Months

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.
Change from Baseline at 12 Months
Change in Six Minute Walk Test
Time Frame: From Baseline at 12 Months
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.
From Baseline at 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Sorajja, MD, Allina Health System
  • Principal Investigator: Gorav Ailawadi, MD, University of Michigan
  • Principal Investigator: Jason Rogers, MD, University of California, Davis
  • Study Director: Kyle Brunner, PhD, Abbott Structural Heart
  • Principal Investigator: Vinod Thourani, MD, Piedmont Healthcare and the Marcus Heart Valve Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CS0004-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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