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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)

NCT04264117 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2020-02-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264117 on ClinicalTrials.gov