Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 11
- Locations
- 4
- Primary Endpoint
- 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)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Device Arm
All subjects will undergo procedure with the Tendyne Mitral Valve System.
Intervention: Tendyne Mitral Valve System (Device)
Outcomes
Primary Outcomes
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)
Time Frame: 30 days post implant
Definition of Device Success: All of the following must be present: 1. Absence of procedural mortality or stroke; and 2. Proper placement and positioning of the device, and 3. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and 4. 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
Secondary Outcomes
No secondary outcomes reported