Protect the Head to Head Study

Study Overview
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Brief Summary
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Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Detailed Description
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Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study to demonstrate safety and effectiveness based on non-inferiority of the study device (Emboliner EPD) compared to the control device (Sentinel CPS) in terms of a 30-day composite major adverse cardiac and cerebrovascular events (MACCE) rate - defined as all death, stroke and Stage 3 acute kidney injury - evaluated on a per-patient basis, post-TAVR procedures

Official Title
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Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device

Conditions
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Embolism

Intervention / Treatment
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* Device: Emboliner Embolic Protection
* Device: Sentinel Cerebral Protection


Participation Criteria
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Eligibility Criteria
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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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: G4: Model Description* Subjects will be randomized (1:1) to either the Emboliner (ARM 1) or Sentinel CPS (ARM 2). Device randomization will be stratified by (a) site and (b) TAVR device type (Edwards or Medtronic) to ensure that each study arm represents an equivalent patient population.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emboliner Embolic Protection Device<br>Emboliner embolic protection device to be used during TAVR procedures for stroke prevention | Device: Emboliner Embolic Protection<br>* Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions<br>* Other names: Embolic protection;|
| Active Comparator: Sentinel Cerebral Protection System<br>Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention | Device: Sentinel Cerebral Protection<br>* The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions<br>* Other names: Embolic protection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority | Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. K4: Description Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. 30 Days | Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority VARC-2 | Non-inferiority of 30-day Emboliner device VARC 2-defined stroke incidence rate compared to the Sentinel device incidence rate. | 30 Days | 
| Debris Capture | The count (by number of particles >150 microns) of debris capture using the Emboliner device will be compared to the count of debris captured by the Sentinel device. | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MACCE, TAVR, Embolism