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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
48
A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGIncident of overt and covert CNS injury 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
Time frame: 7 days post AF ablation
Incident of overt and covert CNS injury 90 days post AF ablation
Incidence of overt and covert CNS injury during or within 90 days of the AF ablation
Time frame: 90 days post AF ablation
Change in neurocognitive function score
Montreal cognitive assessment will administered at baseline and 90 days following ablation. Change in cognitive function score will be compared between the groups. The score ranges from 0 to 30 with higher score indicating better cognitive performance.
Time frame: Baseline, 90 days
New cerebral infarcts
Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group
Time frame: day 1 to 7 after atrial fibrillation ablation
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