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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: FlexAbility (Mesh-like irrigated tip catheter) group; Procedure: TactiCath (Contract force monitoring catheter) group

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 Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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
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	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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Atrial Fibrillation ablation; Prospective randomized trial
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1-2017-0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No