A Comparison of the Drug Therapy Versus Re-Ablation

Phase 2

Completed

• Conditions: Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure
• Interventions: Procedure: re-ablation procedure; Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone); Procedure: ILR implantation

• Registration Number: NCT01709682
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy (control) in patients with previous failed PVI ablation for paroxysmal AF.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2012-01
• Study Completion: 2012-08
• Status Verified: 2012-10
• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-16
• Last Update Submitted: 2012-10-16
• Study First Posted: 2012-10-18
• Last Update Posted: 2012-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• history of symptomatic PAF

Exclusion Criteria

• congestive heart failure
• LV ejection fraction < 35%
• left atrial diameter > 60 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AAD therapy	ILR implantation	Recurrent episodes were pharmacologically managed by conventional AAD therapy (propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure) according to AF management guidelines.
re-ablation procedure	re-ablation procedure	Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by \>80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity. Only in patients with induced left atrial flutter, additional RF ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs.
AAD therapy	Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)	Recurrent episodes were pharmacologically managed by conventional AAD therapy (propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure) according to AF management guidelines.
re-ablation procedure	ILR implantation	Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by \>80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity. Only in patients with induced left atrial flutter, additional RF ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs.

Primary Outcome Measures

Name	Time	Method
progression of AF (AF burden progression and persistent AF)	3 year

Secondary Outcome Measures

Name	Time	Method
recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia	3 years
number of further ablation	3 years
predictors of AF progression	3 years	AF burden by ILR monitoring
complications	3 years	* tamponade; * pulmonary vein stenosis; * atrio-esophora fistula (for re-ablation arm); * ventricular arrhythmia; * symptomatic bradycardia (for AAD arm)

Trial Locations

Locations (1)

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation