CompletedNot Applicable

Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings

China100 participantsStarted 2020-06-17

Plain-language summary

The purpose of this prospective randomized controlled study is to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted magnetic resonance imaging technique.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Patients≥18 years of age prior to obtaining the written informed consent.
✓. Patients with electrocardiographically documented, symptomatic atrial fibrillation.
✓. Patients is scheduled to undergo circumferential pulmonary vein antrum radiofrequency ablation.
✓. Patient or patient's legal representative is able and willing to give informed consent.

Exclusion criteria

✕. Moderate to severe valvular heart disease.
✕. Contraindication for anticoagulation therapy.
✕. Contraindication for Diffusion-Weighted MRI.
✕. Ischemic stroke or transient ischemic attack within 6 months prior to the consent date.
✕. Acute coronary syndrome within 3 months prior to the consent date.
✕. Prior left atrial appendage occlusion device.
✕. Prior septal occlusion device.
✕. Left atrial size greater than 55 mm.

What they're measuring

The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.

Timeframe: Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.

Trial details

NCT IDNCT04408716

SponsorThe Second Affiliated Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-13

View on ClinicalTrials.gov More Atrial Fibrillation trials