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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: FlexAbility (Mesh-like irrigated tip catheter) group
* Procedure: TactiCath (Contract force monitoring catheter) group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FlexAbility (Mesh-like irrigated tip catheter) group<br> | Procedure: FlexAbility (Mesh-like irrigated tip catheter) group<br>* 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<br>|
| Experimental: TactiCath (Contract force monitoring catheter) group<br> | Procedure: TactiCath (Contract force monitoring catheter) group<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month |  | 1 month after the procedure | 
| clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines |  | 12 months after the procedure | 
| clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines |  | 24 months after the procedure | 
| Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission |  | 12 months after the procedure | 
| Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission |  | 24 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time |  | intraoperative | 
| RF energy delivery time |  | within 30 minutes after the procedure | 
| volume of irrigated saline infusion |  | within 30 minutes after the procedure | 
| post-procedural readmission rate |  | 12 months after the procedure | 
| post-procedural readmission rate |  | 24 months after the procedure | 
| post-procedural cardioversion rate |  | 12 months after the procedure | 
| post-procedural cardioversion rate |  | 24 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Atrial Fibrillation ablation, Prospective randomized trial