Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
540 participants
INTERVENTIONAL
2023-05-04
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Emboliner Embolic Protection Device
Emboliner embolic protection device to be used during TAVR procedures for stroke prevention
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 System
Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention
Sentinel Cerebral Protection
The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Emboline
INDUSTRY
Responsible Party
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Principal Investigators
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Laura A Brenton
Role: STUDY_DIRECTOR
Emboline, Inc.
Locations
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NewYork-Presbyterian/Columbia University Medical Center
New York, New York, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Countries
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Central Contacts
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Other Identifiers
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TP-0527
Identifier Type: -
Identifier Source: org_study_id
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