A Comparison of the Drug Therapy Versus Re-Ablation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure

Treatments: Procedure: re-ablation procedure; Procedure: ILR implantation; Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01709682

PAF-DT-RA

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• history of symptomatic PAF

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

AAD therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)

Procedure: ILR implantation

re-ablation procedure

Active Comparator group

Description:

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.

Treatment:

Procedure: re-ablation procedure

Procedure: ILR implantation