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This sub-study was combined to the parent study protocol (NCT04685317)
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral protection with the Sentinel device | Experimental | Subjects who received the Sentinel device in the parent study |
|
| Control group without cerebral protection | Active Comparator | Subjects who did not received the Sentinel device in the parent study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Device | Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ammar Killu, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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
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For both the parent study and the sub-study, participants and investigators will be unblinded.
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| Laboratory Testing | Other | 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 |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |