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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

ProtectH2H Trial 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.Check my eligibility
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.See study design
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.

ProtectH2H Trial 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.

ProtectH2H Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Non-inferiority
Secondary outcome measures
Debris Capture
Non-inferiority VARC-2

ProtectH2H 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
Embolism Research Study Groups: Emboliner Embolic Protection Device, Sentinel Cerebral Protection System
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

Frequently Asked Questions

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

What potential risks accompany the use of Emboliner Embolic Protection Device?

"Due to the nature of this Phase 2 clinical trial, which has some data affirming safety but none that can prove efficacy, our team at Power have conferred Emboliner Embolic Protection Device with a score of 2."

Answered by AI

How many volunteers are participating in this experiment?

"Affirmative. Clinicaltrials.gov displays that this research endeavor, which was first uploaded on May 4th 2023, is currently recruiting participants. The investigators are looking to recruit 540 volunteers from 2 different medical sites."

Answered by AI

Is recruitment for this research program still open?

"Affirmative. Clinicaltrials.gov's data reflects that this clinical trial is currently in the process of recruiting participants; it was originally posted on May 4th 2023 and subsequently revised on May 17th 2023. 540 patients must be sourced from two separate medical centres."

Answered by AI
~202 spots leftby Oct 2024