Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.
Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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
Change in high sensitivity CRP (hs-CRP)
High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Change in interleukin-6 (IL-6)
Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Change in NT-proBNP
NT-proBNP measured in pg/ml to detect changes in tissue damage
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Change in high sensitivity troponin
High sensitivity troponin measure in ng/mL to detect changes in tissue damage
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.