Status:
RECRUITING
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Lead Sponsor:
Malini Madhavan
Conditions:
Arrhythmia
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood de...
Eligibility Criteria
Inclusion
- Men / women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1)
- Able to provide informed consent.
- Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram.
Exclusion
- Anatomy unsuitable for use of Sentinel device:
- Right extremity vasculature not suitable due to compromised arterial blood flow.
- Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (\>70%), dissection or aneurysm.
- Cerebrovascular accident or transient ischemic attack within six months
- Carotid disease requiring treatment within six weeks
- Unable or unwilling to provide informed consent.
- Pregnant women
- Known history of dementia.
- Known hypersensitivity to nickel-titanium.
- Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices.
- The presence of left atrial thrombus. All patients routinely undergo transesophageal echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus.
- Patients with a reversible cause for AF such as hyperthyroidism.
Key Trial Info
Start Date :
March 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04685317
Start Date
March 7 2023
End Date
December 1 2026
Last Update
June 11 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905