Embolism
Conditions
Keywords
MACCE, TAVR, Embolism
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
Interventions
DEVICEEmboliner Embolic Protection
Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
DEVICESentinel Cerebral Protection
The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Sponsors
Emboline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority | Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority VARC-2 | 30 Days | Non-inferiority of 30-day Emboliner device VARC 2-defined stroke incidence rate compared to the Sentinel device incidence rate. |
| Debris Capture | 30 Days | 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. |
Countries
United States
Contacts
Primary ContactLaura A Brenton
Backup ContactDuda Markovic
Outcome results
None listed