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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: FlexAbility (Mesh-like irrigated tip catheter) group; Procedure: TactiCath (Contract force monitoring catheter) group

• Registration Number: NCT04264117
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Last Update Submitted: 2020-02-10
• Study First Posted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2022-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FlexAbility (Mesh-like irrigated tip catheter) group	FlexAbility (Mesh-like irrigated tip catheter) group	-
TactiCath (Contract force monitoring catheter) group	TactiCath (Contract force monitoring catheter) group	-

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission	24 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
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

Secondary Outcome Measures

Name	Time	Method
post-procedural readmission rate	24 months after the procedure
procedure time	intraoperative
RF energy delivery time	within 30 minutes after the procedure
post-procedural cardioversion rate	24 months after the procedure
volume of irrigated saline infusion	within 30 minutes after the procedure

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of