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

Study acronym: SUMMIT
StatusActive, Not Recruiting
PhaseNot applicable
Started2018-06-15
View on ClinicalTrials.gov ↗

Amendment history

2026-07-07
Study Status, Contacts/Locations v32
Study sites78 entries, revised
Ascension Via Christi RegionalHospitals MedicalWichita Northwell CenterHealth - St. Francis Campus South Shore University Hospital Baylor Scott & White The Heart andHospital Vascular- HospitalDallas
2026-05-27
Study Status v31
Re-verified, no change to tracked fields
2026-02-27
Study Status, Contacts/Locations v30
Study sites78 entries, revised
Princeton Baptist Medical Center Princeton HonorHealth Scottsdale Healthcare Shea Medical Center Los Robles Hospital and Medical Center Morton Plant Hospital North Florida Regional Medical Center ShandsBayCare atHealthcare theSystem - Morton Plant Hospital HCA Florida North Florida Hospital University of Florida Wellstar Kennestone HospitalRegional Medical Center Ascension St. Vincent Hospital MedStar HealthUnion ResearchMemorial InstituteHospital University of Michigan Medical Center Henry Ford HospitalHealth St.Saint Luke's Hospital of Kansas City Buffalo General HospitalMedical Center New Y [...] [...]
2025-12-17
Study Status, Outcome Measures, Contacts/Locations, Participant Flow, Outcome Measures (Results) v29
Results first postednot stated→2026-01-08
Secondary endpoints4 entries, revised
Percentage of Participants With Freedom From Mitral Regurgitation (MR) Severity > 1 Change in ProportionPercentage of Participants With NYHA Class I & II
Primary endpoints1 entry, revised
Percentage of Participants With Freedom From All-cause Mortality and Heart Failure Hospitalization (HFH)
Study sitesdetails revised at 1 of 78 sites
2025-11-05
Recruiting→Active, Not Recruiting Study Status, Oversight, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results) v28
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2024-05-15→2024-04-29
Enrollment targetestimated 958→confirmed 103
Study sites80→78
Eligibility criteria+5,400 characters
Inclusion Criteria: 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 [...] NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory). The local site heart team [...] [...]
Secondary endpoints5 to 4 entries
Freedom From Mitral Regurgitation (MR) Severity > 1 Change from baseline in distanceKCCQ walked,Overall asScore Change measuredin byProportion theof 6NYHA Class I & II Change in Six Minute Walk Test (6MWT) Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Change from baseline in health outcomes, as measured by the EQ-5D • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12) Change from bas [...]
Primary endpoints4 to 1 entries
NonFreedom From All-repairablecause Cohort RandomizedMortality Cohort Severeand MACHeart ContinuedFailure Access ProtocolHospitalization (MAC CAPHFH) Cohort Severe Mitral Annular Calcification (MAC) Cohort
Show 27 earlier versions
2025-01-29
Study Status, Oversight, Contacts/Locations v27
Study sites80 entries, revised
MedstarMedStar Health Research Institute SouthsideSouth Shore University Hospital- Northwell Health West Virginia University Hospital Institut de Cardiologie de Montreal (Montreal Heart Institute)
2024-08-01
Study Status, Contacts/Locations v26
Primary completion dateestimated 2024-06→confirmed 2024-05-15
Study sites80 entries, revised
AlleghanyAllegheny General Hospital - ASRI
2024-05-20
Study Status, Contacts/Locations v25
Study sitesdetails revised at 22 of 80 sites
2024-01-24
Study Status, Contacts/Locations v24
Study sites79→80
2023-07-07
Study Status, Contacts/Locations v23
Primary completion date2023-06→2024-06
Completion date2027-06→2028-06
Study sites79 entries, revised
Southside Hospital- Northwell Health Alleghany General Hospital - ASRI St. Thomas HealthHospital
2023-03-21
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v22
Study sites78→79
Study arms4→5
Primary endpoints3 to 4 entries
Severe MAC Continued Access Protocol (MAC CAP) Cohort
2022-06-13
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v21
Primary completion date2022-06→2023-06
Completion date2026-06→2027-06
Study sites74→78
Primary endpoints3 entries, revised
Non-repairable Cohort Severe Mitral Annular Calcification (MAC) Cohort Non-Randomized Cohort
Study title+14 characters
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
2021-06-07
Study Status, Contacts/Locations v20
Study sites67→74
2021-02-01
Study Status, Contacts/Locations v19
Study sites68→67
2021-01-06
Study Status, Contacts/Locations v18
Study sites66→68
2020-12-14
Study Status, Contacts/Locations v17
Study sitescontacts updated at 1 of 66 sites
2020-12-08
Study Status, Contacts/Locations v16
Study sites64→66
2020-11-02
Study Status, Contacts/Locations v15
Study sites36→64
2020-10-20
Study Status, Contacts/Locations v14
Study sites34→36
2020-05-29
Study Status, Contacts/Locations v13
Study sites33→34
2020-04-14
2 amendments v11-v12
2 re-verifications since 2020-01-10, no change to tracked fields
2019-12-19
Study Status, Contacts/Locations v10
Study sites29→33
2019-10-18
2 amendments v8-v9
2 re-verifications since 2019-10-16, no change to tracked fields
2019-08-08
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v7
Enrollment target1010→958
Study sites27→29
Study arms3→4
InterventionsSurgical mitral valve repair or replacement (Device), Tendyne Mitral Valve System (Device)→MitraClip System (Device), Tendyne Mitral Valve System (Device)
Eligibility criteria+447 characters
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 b [...] Not a member of a vulnerable population Exclusion Criteria: Mitral valvular vegetation or mass Left ventricular ejection fraction < 25% Left ventricular en [...] mitral valve involving implantation of prosthetic material Aortic valve disease requiring surgery or transcatheter intervention Severe tricuspid regurgitation or any tricuspid v [...] [...]
Secondary endpoints6 to 5 entries
Freedom from mitral regurgitation > 2+ and without mitral valve reintervention or reoperation Days alive and out of hospital Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT) • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12)
Primary endpoints1 to 3 entries
AMitral compositeAnnular ofCalcification all(MAC) Cohort Non-causeRandomized mortality,Cohort Randomized cardiovascular-related hospitalizations, stroke or mitral valve reintervention or reoperationCohort
2019-05-22
Study Status, Contacts/Locations v6
Study sites20→27
2019-03-01
Study Status, Contacts/Locations v5
Study sites16→20
2018-12-07
Study Status, Contacts/Locations v4
Study sites7→16
2018-10-08
Study Status, Contacts/Locations v3
Study sites3→7
2018-07-01
Withheld→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v2
Trial statusWithheld→Recruiting
Primary completion datenot stated→2022-06
Completion datenot stated→2026-06
Start datenot stated→2018-06-15
Lead sponsor[Redacted]→Abbott Medical Devices
Study title+85 characters
[Clinical Trial to Evaluate the Safety and Effectiveness of device that is not approved or cleared byUsing the U.S.Tendyne FDA]Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
2018-02-19
Study Identification, Study Status v1
Re-verified, no change to tracked fields
2018-02-08
Original filing
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.
Trial Details
NCT Number NCT03433274
Lead Sponsor Abbott Medical Devices
Conditions Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases, Valve Disease, Heart, Heart Valve Diseases, Functional Mitral Regurgitation, Degenerative Mitral Valve Disease
Enrollment 103 participants
Start Date 2018-06-15
Primary Completion 2024-04-29 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-23