Clinical trial NCT02558699: Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
Official title: Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Recurrence rate of atrial fibrillation of 18 months after procedure within 18 months
timeFrame: 18 months
measure: Rate of mortality, incidence of cerebral infarction and hospitalization after procedure
timeFrame: 24 months
Secondary outcomes:
measure: Major complication related procedure : Complication of hemorrhagic and embolic
timeFrame: 24 months
measure: Pericardial effusion required treatment, 4g/dL reduced level of Hb, Hemorrhage required blood transfusion and Cerebral infarction related procedure
timeFrame: 24 months
measure: Procedure time and Radiofrequency ablation time
timeFrame: 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
citation: Choi Y, Lim B, Yang SY, Yang SH, Kwon OS, Kim D, Kim YG, Park JW, Yu HT, Kim TH, Yang PS, Uhm JS, Shim J, Kim SH, Sung JH, Choi JI, Joung B, Lee MH, Kim YH, Oh YS, Pak HN; CUVIA-REGAB Investigators. Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study. Korean Circ J. 2022 Sep;52(9):699-711. doi: 10.4070/kcj.2022.0113. Epub 2022 Jul 11.