Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMagnetic Resonance Imaging (MRI)
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
OTHERLaboratory Testing
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
Sponsors
Boston Scientific Corporation
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
For both the parent study and the sub-study, participants and investigators will be unblinded.
Intervention model description
Parent Study Design: Patients undergoing clinically indicated catheter ablation for AF in the parent study will be randomized 2:1 to two arms: (1) cerebral protection with the Sentinel device and (2) control group without cerebral protection
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included
Exclusion criteria
* Severe peripheral arterial disease that precludes deployment of Sentinel device * Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device * Unable or unwilling to provide informed consent. * Known history of dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New cerebral infarcts | day 1 to 7 after atrial fibrillation ablation | Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group |
| Change in high sensitivity CRP (hs-CRP) | baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation | High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation |
| Change in interleukin-6 (IL-6) | baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation | Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation |
| Change in NT-proBNP | baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation | NT-proBNP measured in pg/ml to detect changes in tissue damage |
| Change in high sensitivity troponin | baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation | High sensitivity troponin measure in ng/mL to detect changes in tissue damage |
Countries
United States
Outcome results
None listed