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Cerebral Protection Device

Sentinel Cerebral Protection System for Atrial Fibrillation

N/A
Recruiting
Led By Malini Madhavan, MBBS
Research Sponsored by Malini Madhavan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men / women over the age of 18 years undergoing radiofrequency or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation
Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram
Must not have
Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (>70%), dissection or aneurysm
Anatomy unsuitable for use of Sentinel device: Right extremity vasculature not suitable due to compromised arterial blood flow
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a cerebral protection device can prevent strokes during AF ablation procedures, and whether cognitive function after the procedure differs for patients who do and do not receive the device.

Who is the study for?
This trial is for men and women over 18 with atrial fibrillation not well-managed by drugs, who can consent and have suitable aortic arch anatomy. It's not for those with certain vascular issues, dementia, pregnancy, MRI non-compatible devices in their body, recent strokes or transient ischemic attacks, hypersensitivity to nickel-titanium or reversible AF causes like hyperthyroidism.
What is being tested?
The study tests if the Sentinel® Cerebral Protection System can prevent strokes during ablation procedures for atrial fibrillation. Participants will either receive this device or not as part of their treatment to compare outcomes including cognitive function post-procedure.
What are the potential side effects?
Potential side effects may include reactions related to the device implantation such as bleeding at the insertion site or allergic reactions to materials in the device (nickel-titanium), although specific side effects are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and will have a procedure for AF as per guidelines.
Select...
My heart's main artery and its branches are the right size and not significantly narrowed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My major neck or chest arteries are not suitable for the procedure due to their shape or condition.
Select...
My right arm's blood flow is not suitable for the Sentinel device.
Select...
I have not had a stroke or mini-stroke in the last six months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 90 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
Incident of overt and covert CNS injury 7 days post AF ablation
Incident of overt and covert CNS injury 90 days post AF ablation
Secondary study objectives
Change in neurocognitive function score
New cerebral infarcts

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: Sentinel® Cerebral Protection System GroupExperimental Treatment2 Interventions
Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Group II: Standard of Care GroupActive Control1 Intervention
Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Sentinel® Cerebral Protection System
2020
N/A
~3000

Find a Location

Who is running the clinical trial?

Malini MadhavanLead Sponsor
Malini Madhavan, MBBSPrincipal InvestigatorMayo Clinic

Media Library

Sentinel® Cerebral Protection System (Cerebral Protection Device) Clinical Trial Eligibility Overview. Trial Name: NCT04685317 — N/A
Atrial Fibrillation Research Study Groups: Sentinel® Cerebral Protection System Group, Standard of Care Group
Atrial Fibrillation Clinical Trial 2023: Sentinel® Cerebral Protection System Highlights & Side Effects. Trial Name: NCT04685317 — N/A
Sentinel® Cerebral Protection System (Cerebral Protection Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04685317 — N/A
~11 spots leftby Jun 2025
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