A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Locations
- 1
- Primary Endpoint
- Change in high sensitivity CRP (hs-CRP)
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Cerebral protection with the Sentinel device
Subjects who received the Sentinel device in the parent study
Intervention: Magnetic Resonance Imaging (MRI) (Device)
Cerebral protection with the Sentinel device
Subjects who received the Sentinel device in the parent study
Intervention: Laboratory Testing (Other)
Control group without cerebral protection
Subjects who did not received the Sentinel device in the parent study
Intervention: Magnetic Resonance Imaging (MRI) (Device)
Control group without cerebral protection
Subjects who did not received the Sentinel device in the parent study
Intervention: Laboratory Testing (Other)
Outcomes
Primary Outcomes
Change in high sensitivity CRP (hs-CRP)
Time Frame: 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 NT-proBNP
Time Frame: 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
New cerebral infarcts
Time Frame: 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 interleukin-6 (IL-6)
Time Frame: 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 high sensitivity troponin
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ammar M. Killu
Principal Investigator
Mayo Clinic