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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Malini Madhavan
Study ID
NCT04685317
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 7, 2023
Status verified
Jun 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Sentinel® Cerebral Protection System Group
    Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
  • Active Comparator: Standard of Care Group
    Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation

Primary Outcome Measure

Incident of overt and covert CNS injury 7 days post AF ablation [ Time Frame: 7 days post AF ablation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Grace Purkey
[email protected]
(507) 255-0774
Malini Madhavan, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Mayo Clinic in Rochester· Rochester, MN

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