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

A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study

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.

Study Overview

• Status: Withdrawn
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: Magnetic Resonance Imaging (MRI); Other: Laboratory Testing

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cerebral protection with the Sentinel device; Subjects who received the Sentinel device in the parent study	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
Active Comparator: Control group without cerebral protection; Subjects who did not received the Sentinel device in the parent study	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Ammar Killu, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20-001308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes