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

Yonsei University

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: TactiCath (Contract force monitoring catheter) group; Procedure: FlexAbility (Mesh-like irrigated tip catheter) group

Study type: Interventional

Funder types: Other

Identifiers

NCT04264117

1-2017-0019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

FlexAbility (Mesh-like irrigated tip catheter) group

Active Comparator group

Treatment:

Procedure: FlexAbility (Mesh-like irrigated tip catheter) group

TactiCath (Contract force monitoring catheter) group

Experimental group

Treatment:

Procedure: TactiCath (Contract force monitoring catheter) group