Skip to Main Content

PROTECT H2H – Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device

  • Study HIC#:2000034603
  • Last Updated:05/07/2024

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

  • Age18 years and older
  • GenderBoth

Contact Us

For more information about this study, including how to volunteer, contact:

Help Us Discover!

You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

Trial Purpose and Description

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

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 procedureSubject 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

Principal Investigator

For more information about this study, including how to volunteer, contact: