A Comparison of the Drug Therapy Versus Re-Ablation

NCT01709682 — Phase 2, Completed, 154 participants, Meshalkin Research Institute of Pathology of Circulation

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Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial Fibrillation: A Randomized Comparison of the Drug Therapy Versus Re-Ablation

Registry	NCT01709682
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	154 (Actual)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Paroxysmal Atrial Fibrillation, Failed First Radiofrequency Ablation Procedure
Interventions	Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone), re-ablation procedure, ILR implantation (Drug, procedure)
Dates	start 2007-11-01, primary completion 2012-01-01, completion 2012-08-01, first posted 2012-10-18, last updated 2012-10-18
Locations	1 site in Russia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
AAD therapy	Active comparator	Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone); Procedure: 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	Active comparator	Procedure: re-ablation procedure; 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.

Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone) (Drug): 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
re-ablation procedure (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.
ILR implantation (Procedure): The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check. Patients were provided with the Patient Assistant, a tool that allows each patient to store the ECG through the implanted device during symptoms; data were collected in order to analyze heart rhythm during symptomatic events.

+Outcome measures

Primary outcomes

progression of AF (AF burden progression and persistent AF) [3 year]

Secondary outcomes

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)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* history of symptomatic PAF

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
State Research Institute of Circulation Pathology	Novosibirsk	Russia

+Publications

Results publication: Pokushalov E, Romanov A, De Melis M, Artyomenko S, Baranova V, Losik D, Bairamova S, Karaskov A, Mittal S, Steinberg JS. Progression of atrial fibrillation after a failed initial ablation procedure in patients with paroxysmal atrial fibrillation: a randomized comparison of drug therapy versus reablation. Circ Arrhythm Electrophysiol. 2013 Aug;6(4):754-60. doi: 10.1161/CIRCEP.113.000495. Epub 2013 Jun 7. PMID 23748210

+Investigators

Evgeny Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology