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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05684146
Other study ID # TP-0527
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 4, 2023
Est. completion date December 2024

Study information

Verified date January 2023
Source Emboline
Contact Laura A Brenton
Phone +1 313 919 8044
Email lbrenton@emboline.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 540
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Emboliner Embolic Protection
Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Sentinel Cerebral Protection
The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions

Locations

Country Name City State
United States NewYork-Presbyterian/Columbia University Medical Center New York New York
United States Oklahoma Heart Institute Tulsa Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
Emboline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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