Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Yonsei University
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
Time Frame: 18 months
Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
Time Frame: 24 months
Secondary Outcomes
- 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)