A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Incident of overt and covert CNS injury 7 days post AF ablation
Study Overview
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 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.
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 debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Sentinel® Cerebral Protection System Group
Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Intervention: Sentinel® Cerebral Protection System (Device)
Sentinel® Cerebral Protection System Group
Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Intervention: Magnetic Resonance Imaging (Diagnostic Test)
Standard of Care Group
Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation
Intervention: Magnetic Resonance Imaging (Diagnostic Test)
Outcomes
Primary Outcomes
Incident of overt and covert CNS injury 7 days post AF ablation
Time Frame: 7 days post AF ablation
Incidence of overt and covert CNS injury confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation
Incident of overt and covert CNS injury 90 days post AF ablation
Time Frame: 90 days post AF ablation
Incidence of overt and covert CNS injury during or within 90 days of the AF ablation
Secondary Outcomes
- Change in neurocognitive function score(Baseline, 90 days)
- New cerebral infarcts(day 1 to 7 after atrial fibrillation ablation)
Investigators
Malini Madhavan
Principal Investigator
Mayo Clinic