A Comparison of the Drug Therapy Versus Re-Ablation

• ClinicalTrials.gov Identifier: NCT01709682
• Recruitment Status: Completed
• First Posted: October 18, 2012
• Last Update Posted: October 18, 2012
• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Information provided by (Responsible Party): Meshalkin Research Institute of Pathology of Circulation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. progression of AF (AF burden progression and persistent AF) [ Time Frame: 3 year ]

Secondary Outcome Measures :

1. recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia [ Time Frame: 3 years ]
2. number of further ablation [ Time Frame: 3 years ]
3. predictors of AF progression [ Time Frame: 3 years ]
   AF burden by ILR monitoring
4. complications [ Time Frame: 3 years ]
   • tamponade
   • pulmonary vein stenosis
   • atrio-esophora fistula (for re-ablation arm)
   • ventricular arrhythmia
   • symptomatic bradycardia (for AAD arm)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• history of symptomatic PAF

Exclusion Criteria:

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

Contacts and Locations

Locations

Russian Federation

State Research Institute of Circulation Pathology

Novosibirsk, Russian Federation, 630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

• Principal Investigator: Evgeny Pokushalov, MD, PhD; State Research Institute of Circulation Pathology

More Information

Additional Information:

State Research Institute of Circulation Pathology Official Site 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: October 18, 2012
• Last Verified: October 2012

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:

atrial fibrillation; arrhythmias; anti-arrhythmic agents

Additional relevant MeSH terms:

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; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Voltage-Gated Sodium Channel Blockers