A Comparison of the Drug Therapy Versus Re-Ablation
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
1 other identifier
interventional
154
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 11, 2012
CompletedFirst Posted
Study publicly available on registry
October 18, 2012
CompletedOctober 18, 2012
October 1, 2012
4.2 years
October 11, 2012
October 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression of AF (AF burden progression and persistent AF)
3 year
Secondary Outcomes (4)
recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
3 years
number of further ablation
3 years
predictors of AF progression
3 years
complications
3 years
Study Arms (2)
AAD therapy
ACTIVE COMPARATORRecurrent 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 COMPARATORReisolation 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.
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- history of symptomatic PAF
You may not qualify if:
- congestive heart failure
- LV ejection fraction \< 35%
- left atrial diameter \> 60 mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
State Research Institute of Circulation Pathology
Novosibirsk, 630055, Russia
Related Publications (1)
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: 23748210DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evgeny Pokushalov, MD, PhD
State Research Institute of Circulation Pathology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2012
First Posted
October 18, 2012
Study Start
November 1, 2007
Primary Completion
January 1, 2012
Study Completion
August 1, 2012
Last Updated
October 18, 2012
Record last verified: 2012-10