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RECRUITING
NCT04685317
NA

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

Sponsor: Malini Madhavan

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2023-03-07

Completion Date

2026-12

Last Updated

2025-06-11

Healthy Volunteers

No

Interventions

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States