Status:
COMPLETED
Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings
Lead Sponsor:
The Second Affiliated Hospital of Chongqing Medical University
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is associated with the...
Eligibility Criteria
Inclusion
- 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
- 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.
- Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion).
- Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study.
- Simultaneous participation in another study.
- Unwilling or unable to comply fully with the study procedures and follow-up requirements.
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04408716
Start Date
June 17 2020
End Date
December 31 2021
Last Update
November 28 2023
Active Locations (1)
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1
The Second Affilliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010