Status:
ACTIVE_NOT_RECRUITING
Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
Lead Sponsor:
Emblok, Inc.
Collaborating Sponsors:
Yale Cardiovascular Research Group
Conditions:
Aortic Valve Stenosis
Aortic Valve Disease
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The objective of the study is to evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device. The...
Detailed Description
Embolic stroke remains a major complication for TAVR, resulting in a two-fold increase in 1-year mortality. Embolic protection devices have been developed to filter embolic debris during the procedure...
Eligibility Criteria
Inclusion
- Clinical Eligibility Criteria:
- Clinical
- Subjects must meet ALL the following criteria to be eligible for participation in the study:
- Subject is between 18 and 90 years of age.
- Subject meets FDA approved indications for TAVR procedure on a native aortic valve using an iliofemoral approach with a commercially approved transcatheter heart valve.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
- Subject agrees to comply with all protocol-specified procedures and assessments.
- Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation.
- Clinical
Exclusion
- Subjects will be excluded if ANY of the following criteria apply:
- Subjects with a previously implanted aortic or mitral valve bioprosthesis
- Subjects with hepatic failure (Child-Pugh class C).
- Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
- Subjects who have a planned treatment with any other investigational device or procedure during the study period.
- Subjects planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 10 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure.
- Subject has experienced an acute myocardial infarction (World Health Organization \[WHO\] criteria) within 30 days of the planned index procedure.
- Subject requires an urgent or emergent TAVR procedure.
- Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min by the Modification of Diet in Renal Disease \[MDRD\] formula).
- Subject has documented history of stroke or transient ischemic attack within prior 6 months, or any prior stroke with a permanent major disability or deficit.
- Subject has an ejection fraction of 30% or less.
- Subject has a sensitivity to contrast media that cannot be adequately pre-treated.
- Subject has known allergy or hypersensitivity to any embolic protection device materials (e.g., nickel-titanium) or allergy to intravascular contrast agents that cannot be pre-medicated
- Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature \> 38°C and/ or white blood cell \> 15,000 IU.
- Subjects undergoing therapeutic thrombolysis.
- Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy.
- Subject is known or suspected to be pregnant, or is lactating.
- Subject is currently participating in another drug or device clinical study, or has other medical illnesses that may cause the subject to be non-compliant with the protocol or confound the data interpretation.
- Anatomic Eligibility Criteria:
- General Anatomic
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT05295628
Start Date
October 17 2023
End Date
October 1 2025
Last Update
August 6 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
2
St Joseph's Providence
Orange, California, United States, 92868
3
Sutter Medical Center Sacramento
Sacramento, California, United States, 95816
4
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93105