Clinical trial NCT04685317: Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Official title: A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrhythmia
Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized study of Sentinel cerebral protection device vs no cerebral protection device in patients undergoing atrial fibrillation ablation.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incident of overt and covert CNS injury 7 days post AF ablation
timeFrame: 7 days post AF ablation
measure: Incident of overt and covert CNS injury 90 days post AF ablation
timeFrame: 90 days post AF ablation
Secondary outcomes:
measure: Change in neurocognitive function score
timeFrame: Baseline, 90 days
measure: New cerebral infarcts
timeFrame: day 1 to 7 after atrial fibrillation ablation
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Malini Madhavan, MBBS
role: PRINCIPAL_INVESTIGATOR
References: