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

Not Applicable

Recruiting

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

• Registration Number: NCT03433274
• Lead Sponsor: Abbott Medical Devices

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 Protocol (MAC CAP). Subjects in the Randomized cohort will be 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 will 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) is 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 will 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 will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2018-06-15
• Primary Completion: 2024-05-15
• Status Verified: 2024-08
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 958

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 been adequately treated per applicable standards
• Not a member of a vulnerable population

Exclusion Criteria

• Mitral valvular vegetation or mass
• Left ventricular ejection fraction < 25%
• Left ventricular end diastolic diameter > 7.0 cm
• Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
• Aortic valve disease requiring surgery or transcatheter intervention
• Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
• Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
• Subject undergoing hemodialysis due to chronic renal failure
• Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
• Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severe Mitral Annular Calcification (MAC) Cohort	1 year	Survival free of heart failure hospitalization at 12 months post index procedure
Randomized Cohort	1 year	Survival free of heart failure hospitalization at 12 months post index procedure
Severe MAC Continued Access Protocol (MAC CAP) Cohort	1 year	Survival free of heart failure hospitalization at 12 months post index procedure
Non-repairable Cohort	1 year	Survival free of heart failure hospitalization at 12 months post index procedure

Secondary Outcome Measures

Name	Time	Method
• Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12)	1 year
Change from baseline in New York Heart Association Classification	1 year
Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	1 year
Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT)	1 year
Change from baseline in health outcomes, as measured by the EQ-5D	1 year

Trial Locations

Locations (80)

MedStar Health Research Institute; 🇺🇸 Balitmore, Maryland, United States

South Shore University Hospital; 🇺🇸 Bay Shore, New York, United States

West Virginia University Hospital; 🇺🇸 Morgantown, West Virginia, United States

Institut de Cardiologie de Montreal (Montreal Heart Institute); 🇨🇦 Montréal, Quebec, Canada

Princeton Baptist Medical Center; 🇺🇸 Birmingham, Alabama, United States

UAB University Hospital; 🇺🇸 Birmingham, Alabama, United States

Banner-University Medical Center; 🇺🇸 Phoenix, Arizona, United States

HonorHealth Scottsdale Shea Medical Center; 🇺🇸 Scottsdale, Arizona, United States

Baptist Health Medical Center; 🇺🇸 Little Rock, Arkansas, United States

Fresno Heart Hospital; 🇺🇸 Fresno, California, United States

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