Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)

Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)

Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)

Mesh-type flexible tip (MFT) catheter is developed to generate bigger radiofrequency (RF) lesion, and contract force (CF) catheter improves the maintenance of catheter-tissue contact during atrial fibrillation catheter ablation (AFCA). The investigators compared clinical outcome of AFCA conducted by MFT catheter and CF catheter in prospective randomized manner. The investigators prospectively assigned 230 patients with AF in a 1:1 ratio to ablation by MFT catheter (FlexAbility™, Abbott Inc. USA) and CF catheter (TactiCath™, Abbott Inc. USA). The primary end point was AF recurrence after single procedure, and the secondary end point was response to antiarrhythmic drugs.

A. Study design Prospective randomization (FlexAbility group vs. TactiCath group ) Target number of subjects: 360 (180 per group) Rhythm follow-up : 2012 ACC/AHA/ESC guidelines (Holter monitoring at the baseline, 2 month, and thereafter every 6 months; ECG if the patient has any symptom) Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines All complications in each group will be evaluated including the re-hospitalization rate, cardioversion frequency, major cardiovascular event, and mortality rate. B. Progress and rhythm/ECG follow-up To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management Follow-up at 2 weeks, 2 months, and thereafter every 6-month. Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter If the patient complains of symptoms, ECG will be performed at any time, and rhythm follow-up will be carried out with a Holter or event recorder.

AF catheter ablation (PV isolation and linear ablations) 30 sec ablation in each point 35W in anterior LA, 30 W in posterior LA Irrigation flow rate 13mL/min Measuring procedure time, Ablation time Rhythm follow-up based on guidelines

AF catheter ablation (PV isolation and linear ablations) contact force >10g, target force-time integral 400 in each point 35W in anterior LA, 30 W in posterior LA Irrigation flow rate 15mL/min at 30W ablation, 30mL/min at 35W ablation Measuring procedure time, Ablation time Rhythm follow-up based on guidelines

procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month

clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines

clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines

Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission

Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission

Inclusion Criteria: Appropriate indiction for AF catheter ablation (20~80 years old) Echocardiographically measured left atrial size < 55mm Anticoagulation eligible patients Exclusion Criteria: AF associated with significant cardiac anomaly, structural heart disease affecting hemodynamics Ineligible to CT imaging due to significant renal disease Prior history of AF catheter ablation or cardiac surgery Active internal bleeding Anticoagulation ineligible patients Valvular AF Life expectancy < 1year Drug or alcohol addicted patients Other unacceptable patients for clinical trial determined by investigators