Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in neurocognitive function score
New cerebral infarcts
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
~1190
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need treatment for my carotid artery within six weeks.My major neck or chest arteries are not suitable for the procedure due to their shape or condition.My right arm's blood flow is not suitable for the Sentinel device.I am over 18 and will have a procedure for AF as per guidelines.My AFib is caused by a treatable condition like an overactive thyroid.My heart's main artery and its branches are the right size and not significantly narrowed.You have implanted medical devices that are not safe for MRI scans.You have a blood clot in your left atrium.You are allergic to nickel-titanium.I have not had a stroke or mini-stroke in the last six months.My AFib symptoms persist despite trying specific heart rhythm medications.
Research Study Groups:
This trial has the following groups:- Group 1: Sentinel® Cerebral Protection System Group
- Group 2: Standard of Care Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to participants in this clinical trial?
"Clinicaltrials.gov indicates that this trial, originally posted on the first day of 2023 and last updated in November 2022, has ceased its search for potential subjects. Despite this, there are presently 508 other medical studies actively looking to recruit patients."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger