A Comparison of the Drug Therapy Versus Re-Ablation
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ClinicalTrials.gov Identifier: NCT01709682 |
Recruitment Status :
Completed
First Posted : October 18, 2012
Last Update Posted : October 18, 2012
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Condition or disease | Intervention/treatment | Phase |
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Paroxysmal Atrial Fibrillation Failed First Radiofrequency Ablation Procedure | Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone) Procedure: re-ablation procedure Procedure: ILR implantation | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
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Active Comparator: AAD therapy
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.
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Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)
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 Procedure: ILR implantation 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. |
Active Comparator: 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. |
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. Procedure: ILR implantation 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. |
- progression of AF (AF burden progression and persistent AF) [ Time Frame: 3 year ]
- recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia [ Time Frame: 3 years ]
- number of further ablation [ Time Frame: 3 years ]
- predictors of AF progression [ Time Frame: 3 years ]AF burden by ILR monitoring
- complications [ Time Frame: 3 years ]
- tamponade
- pulmonary vein stenosis
- atrio-esophora fistula (for re-ablation arm)
- ventricular arrhythmia
- symptomatic bradycardia (for AAD arm)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- history of symptomatic PAF
Exclusion Criteria:
- congestive heart failure
- LV ejection fraction < 35%
- left atrial diameter > 60 mm

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709682
Russian Federation | |
State Research Institute of Circulation Pathology | |
Novosibirsk, Russian Federation, 630055 |
Principal Investigator: | Evgeny Pokushalov, MD, PhD | State Research Institute of Circulation Pathology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Meshalkin Research Institute of Pathology of Circulation |
ClinicalTrials.gov Identifier: | NCT01709682 |
Other Study ID Numbers: |
PAF-DT-RA |
First Posted: | October 18, 2012 Key Record Dates |
Last Update Posted: | October 18, 2012 |
Last Verified: | October 2012 |
atrial fibrillation arrhythmias anti-arrhythmic agents |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Amiodarone Sotalol Flecainide Propafenone Anti-Arrhythmia Agents Vasodilator Agents Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Sodium Channel Blockers |
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