Embolic Protection Devices for Preventing Embolism
(ProtectH2H Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emboline

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Eligibility Criteria

This trial is for adults over 18 with symptomatic severe aortic stenosis eligible for TAVR valve treatment. Participants must consent to follow-up and not have conditions like unicuspid aortic valve, recent heart attack or stroke, severe allergies to specific medications, bleeding disorders, certain mental health issues, or be pregnant.

Inclusion Criteria

I am 18 years old or older.

Willing to participate in study and provide signed EC/IRB-approved informed consent

I have agreed to undergo a TAVR procedure.

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Exclusion Criteria

I do not have dementia or any cognitive issues that prevent me from understanding or following study instructions.

Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment

I am not planning any heart surgery around the time of my TAVR procedure.

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Treatment Details

Interventions

Emboliner Embolic Protection (Embolization Device)
Sentinel Cerebral Protection (Embolization Device)

Trial OverviewThe study compares two devices designed to protect the brain from embolism during TAVR: Emboliner Embolic Protection vs. Sentinel Cerebral Protection. It's an open-label trial where patients are randomly assigned to one of the two arms to assess safety and effectiveness.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Emboliner Embolic Protection DeviceExperimental Treatment1 Intervention

Emboliner embolic protection device to be used during TAVR procedures for stroke prevention

Group II: Sentinel Cerebral Protection SystemActive Control1 Intervention

Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention