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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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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: FlexAbility (Mesh-like irrigated tip catheter) group Procedure: TactiCath (Contract force monitoring catheter) group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: FlexAbility (Mesh-like irrigated tip catheter) group 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
Experimental: TactiCath (Contract force monitoring catheter) group 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission [ Time Frame: 12 months after the procedure ]
  5. Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission [ Time Frame: 24 months after the procedure ]

Secondary Outcome Measures :
  1. procedure time [ Time Frame: intraoperative ]
  2. RF energy delivery time [ Time Frame: within 30 minutes after the procedure ]
  3. volume of irrigated saline infusion [ Time Frame: within 30 minutes after the procedure ]
  4. post-procedural readmission rate [ Time Frame: 12 months after the procedure ]
  5. post-procedural readmission rate [ Time Frame: 24 months after the procedure ]
  6. post-procedural cardioversion rate [ Time Frame: 12 months after the procedure ]
  7. post-procedural cardioversion rate [ Time Frame: 24 months after the procedure ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04264117


Locations
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Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University Health System
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04264117    
Other Study ID Numbers: 1-2017-0019
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Atrial fibrillation
Atrial Fibrillation ablation
Prospective randomized trial
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes