Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
1 other identifier
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Jun 2017
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFebruary 12, 2020
February 1, 2020
4.9 years
February 7, 2020
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
FlexAbility (Mesh-like irrigated tip catheter) group
ACTIVE COMPARATORTactiCath (Contract force monitoring catheter) group
EXPERIMENTALInterventions
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
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
You may qualify if:
- Appropriate indiction for AF catheter ablation (20\~80 years old)
- Echocardiographically measured left atrial size \< 55mm
- Anticoagulation eligible patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 11, 2020
Study Start
June 1, 2017
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
February 12, 2020
Record last verified: 2020-02