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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04264117

Enrollment

360

Registered

2020-02-11

Start date

2017-06-01

Completion date

2022-05-31

Last updated

2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation, Atrial Fibrillation ablation, Prospective randomized trial

Brief summary

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

A. Study design 1. Prospective randomization (FlexAbility group vs. TactiCath group ) 2. Target number of subjects: 360 (180 per group) 3. 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) 4. Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines 5. 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 1. To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management 2. Follow-up at 2 weeks, 2 months, and thereafter every 6-month. 3. Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter 4. 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.

Interventions

PROCEDUREFlexAbility (Mesh-like irrigated tip catheter) group

1. AF catheter ablation (PV isolation and linear ablations) 2. 30 sec ablation in each point 3. 35W in anterior LA, 30 W in posterior LA 4. Irrigation flow rate 13mL/min 5. Measuring procedure time, Ablation time 6. Rhythm follow-up based on guidelines

PROCEDURETactiCath (Contract force monitoring catheter) group

1. AF catheter ablation (PV isolation and linear ablations) 2. contact force \>10g, target force-time integral 400 in each point 3. 35W in anterior LA, 30 W in posterior LA 4. Irrigation flow rate 15mL/min at 30W ablation, 30mL/min at 35W ablation 5. Measuring procedure time, Ablation time 6. Rhythm follow-up based on guidelines

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission	12 months after the procedure

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026