Clinical trial NCT04683692: A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation
Official title: A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2020-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: New cerebral infarcts
timeFrame: day 1 to 7 after atrial fibrillation ablation
measure: Change in high sensitivity CRP (hs-CRP)
timeFrame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
measure: Change in interleukin-6 (IL-6)
timeFrame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
measure: Change in NT-proBNP
timeFrame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
measure: Change in high sensitivity troponin
timeFrame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ammar Killu, MD
role: PRINCIPAL_INVESTIGATOR
References: