Back to resultsA Comparison of the Drug Therapy Versus Re-Ablation
Primary Purpose
Paroxysmal Atrial Fibrillation, Failed First Radiofrequency Ablation Procedure
Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)
re-ablation procedure
ILR implantation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, arrhythmias, anti-arrhythmic agents
Eligibility Criteria
Inclusion Criteria:
- history of symptomatic PAF
Exclusion Criteria:
- congestive heart failure
- LV ejection fraction < 35%
- left atrial diameter > 60 mm
Sites / Locations
- State Research Institute of Circulation Pathology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AAD therapy
re-ablation procedure
Arm 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.
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.
Outcomes
Primary Outcome Measures
progression of AF (AF burden progression and persistent AF)
Secondary Outcome Measures
recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
number of further ablation
predictors of AF progression
AF burden by ILR monitoring
complications
tamponade
pulmonary vein stenosis
atrio-esophora fistula (for re-ablation arm)
ventricular arrhythmia
symptomatic bradycardia (for AAD arm)
Full Information
NCT ID
NCT01709682
First Posted
October 11, 2012
Last Updated
October 16, 2012
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT01709682
Brief Title
A Comparison of the Drug Therapy Versus Re-Ablation
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 Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Failed First Radiofrequency Ablation Procedure
Keywords
atrial fibrillation, arrhythmias, anti-arrhythmic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAD therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
re-ablation procedure
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
re-ablation procedure
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
ILR implantation
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression of AF (AF burden progression and persistent AF)
Time Frame
3 year
Secondary Outcome Measure Information:
Title
recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
Time Frame
3 years
Title
number of further ablation
Time Frame
3 years
Title
predictors of AF progression
Description
AF burden by ILR monitoring
Time Frame
3 years
Title
complications
Description
tamponade
pulmonary vein stenosis
atrio-esophora fistula (for re-ablation arm)
ventricular arrhythmia
symptomatic bradycardia (for AAD arm)
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
history of symptomatic PAF
Exclusion Criteria:
congestive heart failure
LV ejection fraction < 35%
left atrial diameter > 60 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
23748210
Citation
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.
Results Reference
derived
Links:
URL
http://www.meshalkin.ru/
Description
State Research Institute of Circulation Pathology Official Site
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A Comparison of the Drug Therapy Versus Re-Ablation
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