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Active Clinical Trials

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

Active NCT:
03433274
Allegheny General Hospital
Allegheny General Hospital

Sponsor: 
Tendyne Holdings, Inc.
Contact: 

For more information, please contact Tracy Spirk at 412-359-4025 or Tracy.Spirk@ahn.org.

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

Purpose: 

Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive the trial device.

Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)

Sexes Eligible for Study:  All

Accepts Healthy Volunteers:  No

Inclusion Criteria:

Symptomatic, severe mitral regurgitation

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:

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

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.