Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation (CUVIA-AF II)

Yonsei University

Status: Enrolling

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Procedure: physician's personal experience; Procedure: Virtual rotor mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT02558699

4-2015-0646

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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.

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

conventional group

Active Comparator group

Description:

Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation.

Treatment:

Procedure: physician's personal experience

3D atrial computer model

Experimental group

Description:

Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape.

Treatment:

Procedure: Virtual rotor mapping