NCT04685317

Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation

A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Malini Madhavan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.

Detailed description

If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.

Conditions

• Arrhythmia
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Sentinel® Cerebral Protection System	A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
DIAGNOSTIC_TEST	Magnetic Resonance Imaging	Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation

Timeline

• Start date: 2023-03-07
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2020-12-28
• Last updated: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study