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

Atrial Fibrillation Clinical 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04264117
• Other study ID #: 1-2017-0019
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 2022

Study information

• Verified date: February 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• FlexAbility (Mesh-like irrigated tip catheter) group
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
• TactiCath (Contract force monitoring catheter) group
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

Locations

Country	Name	City	State
Korea, Republic of	Severance Cardiovascular Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission		12 months after the procedure
Primary	Major cardiovascular events - death, myocardial infarction, coronary angioplasty, stroke, arrhythmia or heart failure related admission		24 months after the procedure
Secondary	procedure time		intraoperative
Secondary	RF energy delivery time		within 30 minutes after the procedure
Secondary	volume of irrigated saline infusion		within 30 minutes after the procedure
Secondary	post-procedural readmission rate		12 months after the procedure
Secondary	post-procedural readmission rate		24 months after the procedure
Secondary	post-procedural cardioversion rate		12 months after the procedure
Secondary	post-procedural cardioversion rate		24 months after the procedure