Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FlexAbility (Mesh-like irrigated tip catheter) group
TactiCath (Contract force monitoring catheter) group
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Atrial Fibrillation ablation, Prospective randomized trial
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
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FlexAbility (Mesh-like irrigated tip catheter) group
TactiCath (Contract force monitoring catheter) group
Arm Description
Outcomes
Primary Outcome Measures
procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Secondary Outcome Measures
procedure time
RF energy delivery time
volume of irrigated saline infusion
post-procedural readmission rate
post-procedural readmission rate
post-procedural cardioversion rate
post-procedural cardioversion rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04264117
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Prospective randomization (FlexAbility group vs. TactiCath group )
Target number of subjects: 360 (180 per group)
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)
Anticoagulant therapy followed by 2014 ACC/AHA/ESC guidelines
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
To be performed in accordance with the 2012 ACC/AHA/HRS guidelines for AF management
Follow-up at 2 weeks, 2 months, and thereafter every 6-month.
Rhythm control at 2 months, and thereafter every 6-month follow-up with Holter
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation, Atrial Fibrillation ablation, Prospective randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FlexAbility (Mesh-like irrigated tip catheter) group
Arm Type
Active Comparator
Arm Title
TactiCath (Contract force monitoring catheter) group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
FlexAbility (Mesh-like irrigated tip catheter) group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
TactiCath (Contract force monitoring catheter) group
Intervention Description
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
Primary Outcome Measure Information:
Title
procedure related complication rate - open heart surgery, stroke, pericardial tamponade, groin complication, and other procedure related complications within a month
Time Frame
1 month after the procedure
Title
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Time Frame
12 months after the procedure
Title
clinical recurrence rate of AF or AT lasting > 30s. Regular rhythm follow-up based on 2012 ACC/AHA/HRS guidelines
Time Frame
24 months after the procedure
Title
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Time Frame
12 months after the procedure
Title
Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission
Time Frame
24 months after the procedure
Secondary Outcome Measure Information:
Title
procedure time
Time Frame
intraoperative
Title
RF energy delivery time
Time Frame
within 30 minutes after the procedure
Title
volume of irrigated saline infusion
Time Frame
within 30 minutes after the procedure
Title
post-procedural readmission rate
Time Frame
12 months after the procedure
Title
post-procedural readmission rate
Time Frame
24 months after the procedure
Title
post-procedural cardioversion rate
Time Frame
12 months after the procedure
Title
post-procedural cardioversion rate
Time Frame
24 months after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
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