Actively Recruiting
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Led by Malini Madhavan · Updated on 2025-06-11
48
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.
CONDITIONS
Official Title
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women over age 18 undergoing radiofrequency, pulsed field, or cryo-balloon ablation for atrial fibrillation according to current guidelines
- Patients with symptomatic paroxysmal, persistent, or long-standing persistent AF not responsive or intolerant to Class I or III anti-arrhythmic drugs, or before starting such drugs
- Able to provide informed consent
- Acceptable aortic arch anatomy and vessel size without significant narrowing as shown by pre-procedure CT angiogram
You will not qualify if you...
- Unsuitable anatomy for Sentinel device including compromised right extremity blood flow or severe tortuosity, stenosis (>70%), dissection, or aneurysm of brachiocephalic, left carotid, or aortic arch vessels
- Stroke or transient ischemic attack within the past six months
- Carotid disease needing treatment within six weeks
- Unable or unwilling to provide informed consent
- Pregnant women
- Known dementia
- Known allergy to nickel-titanium
- Presence of MRI-incompatible implanted devices including cardiac electronic devices
- Presence of left atrial thrombus confirmed by echocardiogram
- Reversible cause of AF such as hyperthyroidism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
G
Grace Purkey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here