Clinical trial NCT04264117: Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
Official title: Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Atrial Fibrillation ablation
Prospective randomized trial
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month
timeFrame: 1 month after the procedure
measure: clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
timeFrame: 12 months after the procedure
measure: clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
timeFrame: 24 months after the procedure
measure: Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
timeFrame: 12 months after the procedure
measure: Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
timeFrame: 24 months after the procedure
Secondary outcomes:
measure: procedure time
timeFrame: intraoperative
measure: RF energy delivery time
timeFrame: within 30 minutes after the procedure
measure: volume of irrigated saline infusion
timeFrame: within 30 minutes after the procedure
measure: post-procedural readmission rate
timeFrame: 12 months after the procedure
measure: post-procedural readmission rate
timeFrame: 24 months after the procedure
measure: post-procedural cardioversion rate
timeFrame: 12 months after the procedure
measure: post-procedural cardioversion rate
timeFrame: 24 months after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References: