A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04683692
• Other study ID #: 20-001308
• Status: Withdrawn
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Magnetic 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

Other:
• Laboratory 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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials