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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)

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 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04264117
Study type Interventional
Source Yonsei University
Contact
Status Active, not recruiting
Phase N/A
Start date June 1, 2017
Completion date May 2022
View Details
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