Protect the Head to Head Study (ProtectH2H)
Embolism
About this trial
This is an interventional treatment trial for Embolism focused on measuring MACCE, TAVR, Embolism
Eligibility Criteria
Inclusion Criteria: Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines Consented to the TAVR procedure Subject and physician agree that subject will return for required post-procedure follow-up Willing to participate in study and provide signed EC/IRB-approved informed consent Eighteen (18) years or older at the time of consent Exclusion Criteria: Not undergoing a planned TAVR via transfemoral access Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated Uncorrected bleeding disorder Hypercoagulation status that cannot be corrected by additional peri-procedural heparin Myocardial infarction (MI) diagnosis <30 days prior to study procedure History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure <90 mmHg) at time of screening History of a stroke < 180 days prior to study procedure Active peptic ulcer or history of upper gastrointestinal (GI) bleeding < 90 days prior to study procedure Congenital unicuspid aortic valve Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment Hypertrophic cardiomyopathy with or without obstruction Left ventricular ejection fraction (LVEF) ≤20% Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation Active infection or endocarditis Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults Carotid stent placement or endarterectomy performed <180 days prior to study procedure. Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysis Planned treatment with another investigational device or procedure during the study period Balloon valvuloplasty (BAV) within 30 days of the procedure Any planned surgical or interventional cardiac procedure (e.g., concurrent coronary revascularization or AF ablation) during the TAVR procedure, within 30 days before or after the TAVR procedure Emergency surgery for any reason Pregnancy, lactation or intent to become pregnant during study participation Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment Investigator considers participation in the study not to be in the subject's best interest Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature
Sites / Locations
- NewYork-Presbyterian/Columbia University Medical CenterRecruiting
- Oklahoma Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Emboliner Embolic Protection Device
Sentinel Cerebral Protection System
Emboliner embolic protection device to be used during TAVR procedures for stroke prevention
Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention