Evaluation of Safety and Effectiveness of the EMBLOK EPS Compared With No Cerebral Embolic Protection During TAVR

NCT07129421 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLP 002-2025
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

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 TAVR without embolic protection (unprotected TAVR). 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 560 subjects undergoing TAVR at up to 40 investigational sites in the United States. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days, and diffusion-weighted magnetic resonance imaging (DW-MRI) follow-up at 24 to 36 hours post-procedure.

Conditions

AORTIC VALVE DISEASES; Aortic Valve Stenosis and/or Insufficiency; Aortic Valve Regurgitation; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint

  The primary efficacy endpoint is neuroprotection efficacy, determined by pair-wise comparisons among all subjects (Finkelstein-Schoenfeld \[FS\] method1) according to the following prespecified hierarchy of adverse outcomes: * Ischemic stroke (disabling or non-disabling) \[evaluated at 72 hours post-procedure\] * Total lesion volume by DW-MRI \[evaluated at 24-36 hours post-procedure\]

  Evaluated at 72 hours post-procedure (TAVR)

• Primary Safety Endpoint

  The primary safety endpoint is Major Adverse Events, defined as the composite of the following components at 30 days: * All-cause mortality * All stroke (disabling and non-disabling) * Acute kidney injury (Stage 3)

  Evaluated at 30-day post-procedure (TAVR) follow-up visit

Secondary Outcomes (22)

• Combined Safety and Efficacy

  Evaluated post-procedure (day 1), in-hospital (defined as 7 days post-procedure or immediately prior to discharge from the index procedure hospitalization, whichever occurs first)

• Mortality (VARC-2 defined)

  Evaluated immediately after the intervention/procedure, up until discharge from hospital or up until 7 days post procedure, which ever occurs first.

• Neurological Events (VARC-2 and NeuroARC defined)

  Evaluated immediately after the intervention/procedure, up until discharge from hospital or up to 7 days post-procedure, and at the 30 day follow-up visit.

• Incidence of acute kidney injury (AKIN classification)

  Evaluated immediately after the intervention/procedure, up until discharge from hospital or up to 7 days post-procedure, and at the 30 day follow-up visit.]

• Incidence of major vascular complications (VARC-3 defined)

  Evaluated immediately after the intervention/procedure, up until discharge from hospital or up to 7 days post-procedure, and at the 30 day follow-up visit.]

Study Arms (2)

EMBLOK™ Embolic Protection System

EXPERIMENTAL

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 480 subjects meeting eligibility criteria will be randomized 1:1. The experimental "intervention" arm is utilizing EMBLOK EPS during TAVR (up to 240 subjects).

Device: EMBLOK™ Embolic Protection System ("EMBLOK EPS")

Unprotected TAVR

NO INTERVENTION

The control comparator is TAVR without the use of a cerebral embolic protection device ("unprotected TAVR").

Interventions

EMBLOK™ Embolic Protection System ("EMBLOK EPS") DEVICE

The EMBLOK EPS is intended to capture and remove thrombus/debris while performing transcatheter aortic valve replacement procedures.

EMBLOK™ Embolic Protection System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the following criteria to be eligible for participation in the study:
• Subject is ≥ 18 years of age.
• Subject meets FDA approved indications for TAVR 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 14 days 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/EC approved informed consent form prior to study participation.

You may not qualify if:

• Subjects will be excluded if any of the following criteria apply:
• 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, or on dialysis).
• 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 (baseline mRS ≥3).
• 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.

Sponsors & Collaborators

• Emblok, Inc.: lead
• Yale Cardiovascular Research Group: collaborator

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jeremy Moyer

CONTACT

610-509-6727; jeremy@emblok.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. The following individuals will be blinded to the subject's treatment allocation: Site personnel administering neurological evaluations DW-MRI Core Laboratory personnel performing imaging analyses While subjects and their family members will not be blinded, they should not be explicitly informed of their treatment group assignment to minimize the risk of inadvertent unblinding of site personnel administering neurological evaluations.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment This prospective, multicenter, single-blind, randomized controlled trial will enroll up to a total of 560 subjects undergoing TAVR at up to 40 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 80 subjects total), who will not be randomized but will receive the EMBLOK EPS during TAVR. In the randomized cohort, up to 480 subjects meeting eligibility criteria will be randomized 1:1 (stratified by operative risk and study site) to one of two treatment arms: Intervention - EMBLOK EPS during TAVR Control - Unprotected TAVR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 19, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share