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

Running, not enrolling · Not applicable

Conditions studied: Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency, Cardiovascular Diseases, Valve Disease, Heart, Heart Valve Diseases, Functional Mitral Regurgitation, Degenerative Mitral Valve Disease

In brief

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.

Key facts

Study ID

NCT03433274

Run by

Abbott Medical Devices

People needed

103

Starts

2018-06-15

Expected to finish

2028-06-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• UAB University Hospital — Birmingham, Alabama, United States
• Banner-University Medical Center — Phoenix, Arizona, United States
• Scottsdale Healthcare Shea — Scottsdale, Arizona, United States
• Baptist Health Medical Center — Little Rock, Arkansas, United States
• Fresno Heart Hospital — Fresno, California, United States
• University of Southern California University Hospital — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Sutter Medical Center, Sacramento — Sacramento, California, United States
• University of California - Davis Medical Center — Sacramento, California, United States
• San Diego Cardiac Center — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Stanford Health Care — Stanford, California, United States
• Los Robles Regional Medical Center — Thousand Oaks, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Manatee Memorial Hospital — Bradenton, Florida, United States
• BayCare Healthcare System - Morton Plant Hospital — Clearwater, Florida, United States
• Delray Medical Center — Delray Beach, Florida, United States
• HCA Florida North Florida Hospital — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Baptist Hospital of Miami — Miami, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Baptist Medical Center Princeton — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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