We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04264117
Recruitment Status : Unknown
Verified February 2020 by Yonsei University.
Recruitment status was:  Active, not recruiting
First Posted : February 11, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE February 7, 2020
First Posted Date  ICMJE February 11, 2020
Last Update Posted Date February 12, 2020
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission [ Time Frame: 12 months after the procedure ]
  • Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission [ Time Frame: 24 months after the procedure ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • Major cardiovascular events - death, myocardial infarction, coronary angioplasty, storke, arrhythmia or heart failure related admission [ Time Frame: 12 months after the procedure ]
  • Major cardiovascular events - death, myocardial infarction, coronary angioplasty, storke, arrhythmia or heart failure related admission [ Time Frame: 24 months after the procedure ]
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2020)
  • procedure time [ Time Frame: intraoperative ]
  • RF energy delivery time [ Time Frame: within 30 minutes after the procedure ]
  • volume of irrigated saline infusion [ Time Frame: within 30 minutes after the procedure ]
  • post-procedural readmission rate [ Time Frame: 12 months after the procedure ]
  • post-procedural readmission rate [ Time Frame: 24 months after the procedure ]
  • post-procedural cardioversion rate [ Time Frame: 12 months after the procedure ]
  • post-procedural cardioversion rate [ Time Frame: 24 months after the procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Comparison of Contact-force Monitoring Irrigated Tip Catheter and Mesh-like Irrigated Tip Catheter in Atrial Fibrillation Ablation: Prospective Randomized Trial (COMMIC Trial)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Procedure: 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
  • Procedure: 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
Study Arms  ICMJE
  • Active Comparator: FlexAbility (Mesh-like irrigated tip catheter) group
    Intervention: Procedure: FlexAbility (Mesh-like irrigated tip catheter) group
  • Experimental: TactiCath (Contract force monitoring catheter) group
    Intervention: Procedure: TactiCath (Contract force monitoring catheter) group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2020)		 360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04264117
Other Study ID Numbers  ICMJE 1-2017-0019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Yonsei University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Yonsei University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP