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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and evaluated at the time of the tavr procedure (during the intervention/procedure) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

+15 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Innovative Cardiovascular SolutionsLead Sponsor

1 Previous Clinical Trials

28 Total Patients Enrolled

1 Trials studying Aortic Valve Disease

28 Patients Enrolled for Aortic Valve Disease

Yale Cardiovascular Research GroupOTHER

7 Previous Clinical Trials

2,394 Total Patients Enrolled

Hemal Gada, MDPrincipal InvestigatorHeart and Vascular Institute, UPMC Pinnacle

1 Previous Clinical Trials

800 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total participant count for this clinical endeavor?

"Yes, the information posted on clinicaltrials.gov suggests that this medical trial is in active recruitment mode. It was initially uploaded to the site on October 17th 2023 and most recently updated November 7th 2023. The study seeks out 532 patients from a single location."

Answered by AI

Is this trial open to seniors aged 70 and above?

"This medical study allows the recruitment of participants aged 18 and above, all the way up to 90 years old."

Answered by AI

Is enrollment still open for this research endeavor?

"Affirmative. Details hosted on clinicaltrials.gov reconfirms that this medical study—which was initially announced on October 17th 2023—is actively enrolling patients. Around 532 people must be admitted to the single trial site."

Answered by AI

Who meets the criteria to join this medical trial?

"To qualify for this investigation, applicants must have aortic valve disorder and fall between 18 to 90 years old. At the moment, 532 participants are being sought after."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR

2023. "Evaluation of Safety and Effectiveness of the EMBLOK EPS During TAVR". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05295628.

All > Aortic Stenosis