Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification

Conditions
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Mitral Regurgitation, Mitral Insufficiency, Mitral Annular Calcification, Mitral Annulus Calcification, Cardiovascular Diseases, Valve Heart Disease, Heart Valve Diseases, Heart Valve Calcification, Mitral Valve Disease

Intervention / Treatment
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* Device: Tendyne Mitral Valve System


Participation Criteria
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Eligibility Criteria
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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) Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure Myocardial Infarction (MI) within 30 days of the planned implant procedure Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG Cerebrovascular accident (CVA) within six months of planned implant procedure Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound) Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure Severe tricuspid regurgitation or severe right ventricular dysfunction Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology 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 therapy) which cannot be adequately managed medically Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation Known hypersensitivity to nickel or titanium Subject is undergoing hemodialysis due to chronic renal failure ( ≥ Stage 4 CKD) Subject has pulmonary arterial hypertension (fixed PAS >70mmHg) FEV1 < 50% of predicted or < 1L Subject refuses blood transfusions Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use Pregnant, lactating, or planning pregnancy within next 12 months. Currently participating in an investigational drug or another device trial that has not reached its primary endpoint Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Arm<br>All subjects will undergo procedure with the Tendyne Mitral Valve System. | Device: Tendyne Mitral Valve System<br>* Mitral valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Definition of Device Success: All of the following must be present: Absence of procedural mortality or stroke; and Proper placement and positioning of the device, and Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and Continued intended safety and performance of the device, including: i. No evidence of structural or functional failure ii. No specific device-related technical failure issues or complications iii. Reduction of MR to either optimal or acceptable levels without significant structural valve dysfunction and with no greater than mild (1+) paravalvular MR (and without associated hemolysis). All device- or procedure-related adverse events will be adjudicated by an independent clinical events committee | 30 days post implant |