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

General Information Age Group Adults Status Recruiting Protocol Number NCT03433274 Background Information To evaluate the safety and effectiveness of the Tendyne™ 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. Offered At Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 Principal Investigator Wayne Batchelor, MD Eligibility Information 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 conventional mitral valve surgery by the local site heart team Note: MR 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 Subject Eligibility Committee must concur that the subject has been adequately treated The local site heart team and the Subject Eligibility Committee 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 amenable to transcatheter edge-to-edge repair within approved MitraClip indications. 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. Non-randomized cohort: Eligibility for this cohort is limited to subjects where the local site heart team deems the mitral valve anatomy is not amenable for transcatheter repair with MitraClip or does not meet MitraClip indications. 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 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. Ineligibility Information Mitral valvular vegetation or mass Left Ventricle (LV) or Left Atrium (LA) thrombus Chest condition that prevents transapical access Left Ventricular Ejection Fraction (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 must be confirmed by the Echocardiography Core Laboratory. Left Ventricular End Diastolic Diameter (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 MitraClip) Mitral pathoanatomy and Left Ventricular Outflow Tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation Aortic valve disease requiring surgery or transcatheter intervention Additional information can be found at https://clinicaltrials.gov/ct2/show/NCT03433274 Contact Information Contact Name Brian Moore RN Contact Phone 703-776-7995 Contact Email Send Email