Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR
NCT ID: NCT05295628
Last Updated: 2025-08-06
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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ACTIVE_NOT_RECRUITING
NA
532 participants
INTERVENTIONAL
2023-10-17
2025-10-01
Brief Summary
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This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.
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Detailed Description
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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. With this comparator device, the left subclavian artery and descending aorta are not protected.
The targeted study population consists of patients meeting FDA-approved indications for TAVR with commercially available transcatheter heart valve systems.
This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 532 subjects undergoing TAVR at up to 30 investigational sites in the United States.
Prior to enrollment of the first randomized subject at each site, each site will enroll 2 Roll-In subjects (up to 60 subjects total), who will not be randomized but will receive the EMBLOK EPS during TAVR.
In the randomized cohort, up to 422 subjects meeting eligibility criteria will be randomized 1:1 (stratified by operative risk and study site) to one of two treatment arms:
1. Intervention - EMBLOK EPS during TAVR
2. Control - SENTINEL CPS during TAVR
In addition, a nested registry will enroll up to 50 subjects who meet clinical eligibility criteria and are anatomically suitable for the EMBLOK EPS, but whose anatomy precludes the use of the SENTINEL CPS.
All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Prior to enrollment of the first randomized subject at each site, each site will enroll 2 Roll-In subjects (up to 60 subjects total), who will not be randomized but will receive the EMBLOK EPS during TAVR.
In the randomized cohort, up to 422 subjects meeting eligibility criteria will be randomized 1:1 (stratified by operative risk and study site) to one of two treatment arms:
1. Intervention - EMBLOK EPS during TAVR
2. Control - SENTINEL CPS during TAVR
In addition, a nested registry will enroll up to 50 subjects who meet clinical eligibility criteria and are anatomically suitable for the EMBLOK EPS, but whose anatomy precludes the use of the SENTINEL CPS.
PREVENTION
DOUBLE
* The subject and his or her family members
* Site personnel administering neurological evaluations
* Pathology Core Laboratory personnel performing debris analyses
Un-blinding will occur only after the database has been locked for the analysis of the primary endpoint or to protect subject rights, welfare, or well-being at the request of the DMC. A site investigator may also reveal treatment allocation to an individual subject if deemed necessary due to complication or injury.
Study Groups
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EMBLOK™ Embolic Protection System
Device Description:
The EMBLOK™ Embolic Protection System ("EMBLOK EPS") is a sterile, single use system designed to capture and remove debris (e.g., thrombus, calcium, atheroma) dislodged during transcatheter aortic valve replacement (TAVR) procedures. The device is currently for investigational use only.
When Device Will Be Used:
Roll-in: Prior to enrollment of the first randomized subject at each site, each site will enroll 2 Roll-In subjects, who will not be randomized but will receive the EMBLOK EPS during TAVR.
Randomized: Up to 422 subjects meeting eligibility criteria will be randomized 1:1. The experimental "intervention" arm is utilizing EMBLOK EPS during TAVR (up to 211 subjects).
Nested registry: Up to 50 subjects who meet clinical eligibility criteria and are anatomically suitable for the EMBLOK EPS, but whose anatomy precludes the use of the SENTINEL CPS.
EMBLOK™ Embolic Protection System ("EMBLOK EPS")
The EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
SENTINEL™ Cerebral Protection System
Device Description:
The control comparator is the commercially-available SENTINEL™ Cerebral Protection System ("SENTINEL CPS") (Boston Scientific Corp., Marlborough, MA, US), a dual-filter protection device designed to capture and remove debris dislodged during TAVR procedures.
The SENTINEL CPS is indicated for use as an embolic protection device to capture and remove thrombus/debris while performing TAVR procedures. The diameters of the arteries at the site of filter placement should be between 9.0 mm - 15.0 mm for the brachiocephalic and 6.5 mm - 10.0 mm in the left common carotid.
When Device Will Be Used:
In the randomized cohort, up to 422 subjects meeting eligibility criteria will be randomized 1:1 (stratified by operative risk and study site). The active comparator "control" arm is utilizing SENTINEL CPS during TAVR (up to 211 subjects).
SENTINEL™ Cerebral Protection System
The SENTINEL CPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
Interventions
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EMBLOK™ Embolic Protection System ("EMBLOK EPS")
The EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
SENTINEL™ Cerebral Protection System
The SENTINEL CPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.
Eligibility Criteria
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Inclusion Criteria
1. Subject is between 18 and 90 years of age.
2. Subject meets FDA approved indications for TAVR procedure on a native aortic valve using an iliofemoral approach with a commercially approved transcatheter heart valve.
3. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
4. Subject agrees to comply with all protocol-specified procedures and assessments.
5. Subject or subject's legal representative signs an IRB approved informed consent form prior to study participation.
Exclusion Criteria
1. Subjects with a previously implanted aortic or mitral valve bioprosthesis
2. Subjects with hepatic failure (Child-Pugh class C).
3. Subjects with hypercoagulable states that cannot be corrected by additional periprocedural heparin.
4. Subjects who have a planned treatment with any other investigational device or procedure during the study period.
5. 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.
6. Subject has experienced an acute myocardial infarction (World Health Organization \[WHO\] criteria) within 30 days of the planned index procedure.
7. Subject requires an urgent or emergent TAVR procedure.
8. Subjects with renal failure (estimated Glomerular Filtration Rate \[eGFR\] \< 30 mL/min by the Modification of Diet in Renal Disease \[MDRD\] formula).
9. 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.
10. Subject has an ejection fraction of 30% or less.
11. Subject has a sensitivity to contrast media that cannot be adequately pre-treated.
12. 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
13. Subject has active endocarditis or an ongoing systemic infection defined as fever with temperature \> 38°C and/ or white blood cell \> 15,000 IU.
14. Subjects undergoing therapeutic thrombolysis.
15. Subject has history of bleeding diathesis or a coagulopathy or contraindications to anticoagulation and antiplatelet therapy.
16. Subject is known or suspected to be pregnant, or is lactating.
17. 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:
Subjects meeting any of the following criteria will not be eligible for participation in the study:
1. Non-iliofemoral approach for is required for the TAVR system (e.g., trans-axillary, trans-subclavian, trans-brachiocephalic, trans-carotid, trans-apical or trans-aortic access for TAVR is required).
2. Subject peripheral anatomy is not compatible with contralateral iliofemoral access with an 11 French catheter (e.g., due to excessive tortuosity, stenosis, ectasia, dissection, or aneurysm).
3. Ascending aorta length (from the site of filter placement to the aortic root) less than 7.5 cm.
4. Diameter of the aorta at the intended site of Emblok filter deployment proximal to the brachiocephalic artery ostium is less than 25 mm or greater than 40 mm.
5. Subjects with severe peripheral arterial, abdominal aortic, or thoracic aortic disease that precludes delivery sheath vascular access.
6. Subjects in whom the aortic arch is heavily calcified, severely atheromatous, or severely tortuous.
Subjects with any of the following criteria will be excluded from participation in the Randomized Cohort, but are eligible for participation in the Roll-In and Nested Registry cohorts (provided they meet all other eligibility criteria):
1. Diameters of the arteries at the site of filter placement are \< 9 or \> 15 mm for the brachiocephalic artery or \< 6.5 or \>10 mm in the left common carotid.
2. Brachiocephalic or carotid vessel with excessive tortuosity.
3. Compromised blood flow to the right upper extremity, or other conditions that would preclude 6 Fr radial or brachial vascular access (e.g., excessive tortuosity)
4. Arterial stenosis \>70% in either the left common carotid artery or the brachiocephalic artery.
5. Brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
18 Years
90 Years
ALL
No
Sponsors
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Yale Cardiovascular Research Group
OTHER
Emblok, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hemal Gada, MD
Role: PRINCIPAL_INVESTIGATOR
Heart and Vascular Institute, UPMC Pinnacle
Locations
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Dignity Health Chandler Regional Medical Center
Chandler, Arizona, United States
St Joseph's Providence
Orange, California, United States
Sutter Medical Center Sacramento
Sacramento, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Hartford Hospital
Hartford, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Ascension Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
University of Washington School of Medicine Barnes Jewish Hospital
St Louis, Missouri, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research
Plano, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Sentra Norfolk General Hospital
Norfolk, Virginia, United States
Countries
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Other Identifiers
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CLP 001-2021
Identifier Type: -
Identifier Source: org_study_id
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