Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
NCT ID: NCT04264117
Last Updated: 2020-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2017-06-01
2022-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FlexAbility (Mesh-like irrigated tip catheter) group
FlexAbility (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
TactiCath (Contract force monitoring catheter) group
TactiCath (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
Interventions
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FlexAbility (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
TactiCath (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
Eligibility Criteria
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Inclusion Criteria
* Echocardiographically measured left atrial size \< 55mm
* Anticoagulation eligible patients
Exclusion Criteria
* 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
20 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, , South Korea
Countries
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Other Identifiers
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1-2017-0019
Identifier Type: -
Identifier Source: org_study_id
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