Clinical trial NCT05684146: Protect the Head to Head Study
Official title: Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Embolism
Keywords: MACCE
TAVR
Embolism
Lead sponsor: Emboline
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Detailed 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:

1. Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines
2. Consented to the TAVR procedure
3. Subject and physician agree that subject will return for required post-procedure follow-up
4. Willing to participate in study and provide signed EC/IRB-approved informed consent
5. Eighteen (18) years or older at the time of consent

Exclusion Criteria:

1. Not undergoing a planned TAVR via transfemoral access
2. Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated
3. Uncorrected bleeding disorder
4. Hypercoagulation status that cannot be corrected by additional peri-procedural heparin
5. Myocardial infarction (MI) diagnosis \<30 days prior to study procedure
6. History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
7. Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure \<90 mmHg) at time of screening
8. History of a stroke \< 180 days prior to study procedure
9. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding \< 90 days prior to study procedure
10. Congenital unicuspid aortic valve
11. Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
12. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
13. Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment
14. Hypertrophic cardiomyopathy with or without obstruction
15. Left ventricular ejection fraction (LVEF) ≤20%
16. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
17. Active infection or endocarditis
18. Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults
19. Carotid stent placement or endarterectomy performed \<180 days prior to study procedure.
20. Severe renal insufficiency (creatinine \>3.0 mg/dL or GFR \<30 mL/min) or patient on dialysis
21. Planned treatment with another investigational device or procedure during the study period
22. Balloon valvuloplasty (BAV) within 30 days of the procedure
23. 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
24. Emergency surgery for any reason
25. Pregnancy, lactation or intent to become pregnant during study participation
26. 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
27. Investigator considers participation in the study not to be in the subject's best interest
28. Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol
29. Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature

Primary outcomes:
measure: Non-inferiority
timeFrame: Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate.
Secondary outcomes:
measure: Non-inferiority VARC-2
timeFrame: 30 Days
measure: Debris Capture
timeFrame: 30 Days
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian/Columbia University Medical Center
state: New York
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
Study officials:
affiliation: Emboline, Inc.
name: Laura A Brenton
role: STUDY_DIRECTOR
References: