Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: conventional ablation based on physician's personal experience; Procedure: Virtual ablation in based 3D CT of patient who diagnosed AF

• Registration Number: NCT02171364
• Lead Sponsor: Yonsei University

Brief Summary

Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Study Start: 2014-08
• Primary Completion: 2015-09-01
• Study Completion: 2015-09-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

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Exclusion Criteria

• AF patients who have severe heart deformations or blood problems.
• The patients who had been performed catheter ablation of atrial ablation.
• The patients who missed out to recording of 3D CT, echo and electrocardiography.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional ablation	conventional ablation based on physician's personal experience	The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.
virtual simulation	Virtual ablation in based 3D CT of patient who diagnosed AF	This intervention group is to choose the best effective method operation to patients by simulating 3D atrial computer model which consider patient's heart size and shape.

Primary Outcome Measures

Name	Time	Method
change of hospitalization rate	1, 3, 6, 12, 18 and 24 months after catheter ablation and every 6 months thereafter.

Secondary Outcome Measures

Name	Time	Method
occurence of cardiovascular disease	6 months
recurrence of AF	6 months

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of