Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

NCT05295628 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLP 001-2021
• Study Type: interventional
• Target: 532
• Locations: 1 country
• Sites: 23

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 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. All subjects will undergo clinical follow-up (including detailed neurological assessments) in-hospital and at 30 days.

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Insufficiency; Aortic Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Incidence of the composite of all-cause mortality, all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), according to VARC-2 definitions

  The primary safety and efficacy endpoint is combined safety and efficacy at 30 days, defined as a composite of the following VARC-2 defined components: * All-cause mortality * All stroke (disabling or non-disabling) and transient ischemic attack (TIA) * Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy)

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

• Debris capture, defined as the average number of captured particles ≥150 µm in diameter, as assessed by independent histologic analysis

  The co-primary filtration efficacy endpoint is debris capture, defined as the average number of captured particles ≥150 μm in diameter, as assessed by independent histologic analysis.

  Evaluated at the time of the TAVR procedure (during the intervention/procedure)

Secondary Outcomes (18)

• Incidence of the composite of all-cause mortality, all stroke (disabling or non-disabling) and transient ischemic attack (TIA), and Acute Kidney Injury Stage 2 or 3 (including renal replacement therapy), according to VARC-2 definitions

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

• Incidence of all-cause mortality (VARC-2 defined), subclassified as cardiovascular or non-cardiovascular mortality

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

• Incidence of stroke (sub-classified as ischemic, hemorrhagic, or undetermined, and as disabling or non-disabling) and TIA, according to VARC-2 and NeuroARC definitions

  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), subclassified as stage 1, 2, or 3

  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 life-threatening or disabling bleeding and major bleeding (VARC-2 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 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.

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

SENTINEL™ Cerebral Protection System

ACTIVE COMPARATOR

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).

Device: SENTINEL™ Cerebral Protection System

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

SENTINEL™ Cerebral Protection System DEVICE

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

SENTINEL™ Cerebral Protection System

Eligibility Criteria

• Age: 18 Years - 90 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (23)

Dignity Health Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

St Joseph's Providence

Orange, California, 92868, United States

Location

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

Ascension Via Christi Hospitals Wichita, Inc.

Wichita, Kansas, 67226, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

University of Washington School of Medicine Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, 17101, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19091, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Baylor Scott and White The Heart Hospital Plano- Baylor Institute of Research

Plano, Texas, 75093, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Sentra Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Hemal Gada, MD

  Heart and Vascular Institute, UPMC Pinnacle

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study. The following individuals will be blinded to the subject's treatment allocation: * 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 25, 2022
• Study Start: October 17, 2023
• Primary Completion: May 6, 2025
• Study Completion: October 1, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)