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Embolization Device

Embolic Protection Devices for Preventing Embolism (ProtectH2H Trial)

Phase 2
Recruiting
Research Sponsored by Emboline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eighteen (18) years or older at the time of consent
Consented to the TAVR procedure
Must not have
Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol
Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at the safety and effectiveness of a new medical treatment in multiple locations.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include risks associated with device implantation such as vascular complications, allergic reactions to device materials (nitinol), bleeding due to anti-clotting medication used during the procedure, and possible interference with heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have agreed to undergo a TAVR procedure.
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I am approved for a heart valve replacement due to severe narrowing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have dementia or any cognitive issues that prevent me from understanding or following study instructions.
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I have severe aortic calcification or other specific aorta conditions.
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I have a heart valve replacement or severe mitral valve leak.
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I have a current blood disorder that needs treatment.
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I do not have severe heart problems like cardiogenic shock or need help to maintain my blood pressure.
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I do not have an active infection or endocarditis.
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I have had emergency surgery recently.
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I have a progressive brain disorder or had a serious head injury with lasting effects.
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I am not scheduled for a TAVR procedure through the leg.
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My blood clots too easily and heparin doesn't help.
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I had a heart attack less than 30 days ago.
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I had a procedure to open my neck artery less than 6 months ago.
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I was born with a one-flap aortic valve.
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I have a dialysis access point like a shunt, graft, or fistula.
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I have a thickened heart muscle, with or without blockage.
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I have a bleeding disorder that hasn't been treated.
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I have severe kidney problems or am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Non-inferiority
Secondary study objectives
Debris Capture
Non-inferiority VARC-2

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: 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

Find a Location

Who is running the clinical trial?

EmbolineLead Sponsor
Laura A BrentonStudy DirectorEmboline, Inc.
5 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Emboliner Embolic Protection (Embolization Device) Clinical Trial Eligibility Overview. Trial Name: NCT05684146 — Phase 2
Prophylaxis of Embolism Research Study Groups: Emboliner Embolic Protection Device, Sentinel Cerebral Protection System
Prophylaxis of Embolism Clinical Trial 2023: Emboliner Embolic Protection Highlights & Side Effects. Trial Name: NCT05684146 — Phase 2
Emboliner Embolic Protection (Embolization Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05684146 — Phase 2
~202 spots leftby Jan 2026
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