Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation

Not Applicable

Recruiting

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: Virtual rotor mapping; Procedure: physician's personal experience

• Registration Number: NCT02558699
• Lead Sponsor: Yonsei University

Brief Summary

Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal atrial fibrillation. In order to reduce 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 conduct virtual rotor mapping in the patient specific atrial model. Then, the investigators will compare the clinical outcome of conventional circumferential pulmonary vein isolation and additional rotor ablation guided by virtual rotor mapping.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Study Start: 2018-08-24
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2023-01-03
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• AF patient age 19~80
• 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 vascular disease.
• The patient who have renal disease of eGFR<30mL/min
• The patients who had been performed catheter ablation of atrial ablation and MAZE.
• The patients who missed out to recording of 3D CT, echo and electrocardiography.
• the patient have experienced major hemorrhagic complication
• The patient have experienced ischemic cerebral infarction more 2 times
• The patient who have risk of ischemic cerebral infarction (CHA2DS2-VASc Score >5)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D atrial computer model	Virtual rotor mapping	Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape.
conventional group	physician's personal experience	Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation.

Primary Outcome Measures

Name	Time	Method
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months	18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure	24 months

Secondary Outcome Measures

Name	Time	Method
Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure	24 months
Procedure time and Radiofrequency ablation time	24 months
Major complication related procedure : Complication of hemorrhagic and embolic	24 months

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of