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Embolic Protection Device

EMBLOK EPS for Aortic Valve Disease

N/A

Recruiting

Led By Hemal Gada, MD

Research Sponsored by Innovative Cardiovascular Solutions

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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)

Ascending aorta length (from the site of filter placement to the aortic root) less than 7.5 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evaluated at the time of the tavr procedure (during the intervention/procedure)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new device to protect against stroke during a valve replacement procedure. It will involve 532 people in 30 US sites and assess its safety and effectiveness.

Who is the study for?

This trial is for adults aged 18-90 with aortic valve disease needing TAVR and can follow the study plan. Pregnant or breastfeeding women, those with recent heart attacks, urgent TAVR needs, allergies to device materials or contrast agents that can't be managed, severe liver/renal failure, bleeding disorders, history of stroke or major disability from it, ejection fraction ≤30%, and certain anatomical issues are excluded.

What is being tested?

The EMBLOK EPS is being tested against the SENTINEL Cerebral Protection System during TAVR procedures in patients with aortic valve disease. The goal is to compare safety and effectiveness through randomized assignment at multiple U.S. centers with follow-ups including neurological assessments.

What are the potential side effects?

Potential side effects may include allergic reactions to device materials like nickel-titanium or contrast agents used during the procedure (if pre-medication isn't effective), complications related to vascular access for the devices such as bleeding or vessel damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old.

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I am eligible for a TAVR procedure on my heart valve using an approved method.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My right arm's blood flow is not restricted, and it can support minor medical procedures.

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The length of my ascending aorta is less than 7.5 cm.

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My veins are not suitable for a specific catheter due to their shape or condition.

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My aortic arch is heavily calcified or very twisted.

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My kidney function is severely reduced.

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I have a major artery that is more than 70% blocked.

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My blood clots too easily and heparin doesn't help.

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I have a major neck artery issue near the heart's main artery.

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My neck arteries are excessively twisted.

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I have severe artery disease that prevents certain medical procedures.

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I have had a stroke or mini-stroke in the last 6 months, or a stroke before that has left me with major lasting effects.

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I had a heart attack within the last 30 days.

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I need an urgent heart valve replacement.

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I have severe liver disease.

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My heart's pumping ability is severely reduced.

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I am currently receiving treatment to dissolve blood clots.

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I have a bleeding disorder or can't take blood thinners.

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I do not have an ongoing fever over 38°C or a high white blood cell count.

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I need a TAVR procedure not through the groin area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Diameter of captured particles (in mm), as assessed by an independent Pathology Core Laboratory

Incidence of acute kidney injury (AKIN classification), subclassified as stage 1, 2, or 3

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

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EMBLOK™ Embolic Protection SystemExperimental Treatment1 Intervention

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.

Group II: SENTINEL™ Cerebral Protection SystemActive Control1 Intervention

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).

0 / 21Eligibility criteria met