Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification (NCT03539458) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification
United States11 participantsStarted 2018-10-10
Plain-language summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation
✓. Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR
✓. NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
✓. Age 18 years or older at time of consent
✓. Not a member of a vulnerable population per the investigator's judgment
✓. The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent
Exclusion criteria
✕. Presence of Left Ventricle or Left Atrium thrombus
✕. Chest condition that prevents transapical access
✕. Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram
✕. Left Ventricular End Diastolic Dimension (LVEDD) \> 7.0 cm
✕. Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy
✕. Prior intervention with permanently implanted mitral device (e.g. MitraClip)
What they're measuring
1
Number of Participants With Composite Endpoint of Device Success and Freedom From Device or Procedure Related Serious Adverse Events (SAEs), as Classified by the Clinical Events Committee (CEC)