Comparison Between Contact Force Guided and Blinded Strategy on PV Isolation in AF Patients

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: SmartTouch Catheter

• Registration Number: NCT02924181
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Pulmonary vein (PV) isolation is very important in atrial fibrillation (AF) catheter ablation. PV reconnection is one of the main reasons in AF recurrence. Contact force-sensing catheter is a new catheter which has valuable tools to monitor and increase the efficacy of PV isolation. Previous paper reported the efficacy of contact force-sensing catheter on immediate PV isolation and outcome. However, there might be confounding factor as inter-individual variation. Therefore, we would like to compare the efficacy of contact force-sensing catheter within same patient but different veins.

In this study, we would like to confirm the efficacy of contact force-sensing catheter on immediate PV isolation outcome within same patient. This study randomized the right or left PVs whether to use the contact force-sensing function or not. The study design will minimize the inter-individual variation on evaluating the efficacy of contact force-sensing catheter on immediate PV isolation.

Also, in patients who had recurred AF or AT, we would like to evaluate the long-term efficacy of contact force-sensing catheter on PV isolation.

Detailed Description

Sixty patients will be randomized to select right or left pulmonary veins whether to apply contact force-guided ablation or contact force-blinded ablation strategy. Each PV will be ablated with same contact force-sensing catheter (Thermocool Smart Touch Catheter, Biosense Webster Inc. CA). The PV (right or left) which will be randomized to contact force-sensing PV or blind PV. Contact force-sensing PV will be ablated guided by contact force, whereas the blind PVs will be ablated without contact force-sensing information. The change of impedance, total ablation and time to ablate PV will be collected and analysed according to contact force-sensing strategy. After exit and entrance block by conventional method, dormant conduction will be evaluated by using adenosine. The proportion of dormant conduction will be compared between contact force-sensing guided or blinded strategy.

During 1-year follow up, patients who recurred AF or AT will be undergo second ablation procedure. In these patients, PV reconnection rate will be evaluated by a duodecapolar lasso circular mapping catheter. We would like to know whether PVs which have ablated with contact force-sensing information at index procedure have less reconnection than those which was ablated without contact force-sensing information.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Primary Completion: 2017-10-23
• Study Completion: 2018-10-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with symptomatic paroxysmal atrial fibrillation (AF) who had failed with anti-arrhythmic agents.

Exclusion Criteria

• Patients who had previous ablation for AF
• Patients with symptomatic persistent AF

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lt PV CF guided/rt PV CF blinded	SmartTouch Catheter	Fifteen patients will be allocated to this group. Left side pulmonary veins isolation will be performed with contact force information guidance. Then, right side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).
Lt PV CF blinded/rt PV CF guided	SmartTouch Catheter	Fifteen patients will be allocated to this group. Left side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).Then, right side pulmonary veins isolation will be performed with contact force information guidance.
Rt PV CF guided/lt PV CF blinded	SmartTouch Catheter	Fifteen patients will be allocated to this group. Right side pulmonary veins isolation will be performed with contact force information guidance. Then, left side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter).
Rt PV CF blinded/lt PV CF guided	SmartTouch Catheter	Fifteen patients will be allocated to this group. Right side pulmonary veins isolation will be performed without contact force information (using same catheter named SmartTouch Catheter). Then, left side pulmonary veins isolation will be performed with contact force information guidance.

Primary Outcome Measures

Name	Time	Method
Proportion of immediate PV isolation ratio after final ablation according to contact force-guided ablation, change of impedance, total ablation time, and procedure time according to contact force-guided strategy	Immediate after PV isolation (acute result)

Secondary Outcome Measures

Name	Time	Method
Proportion of PV reconnection according to contact force-guided ablation in patients with AF recurrence	1 year

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of