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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01709682
Enrollment
154
Registered
2012-10-18
Start date
2007-11-30
Completion date
2012-08-31
Last updated
2012-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed First Radiofrequency Ablation Procedure, Paroxysmal Atrial Fibrillation

Keywords

atrial fibrillation, arrhythmias, anti-arrhythmic agents

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.

Interventions

DRUGAnti-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

PROCEDUREre-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.

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.

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* history of symptomatic PAF

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
progression of AF (AF burden progression and persistent AF)3 year

Secondary

MeasureTime frameDescription
recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia3 years
number of further ablation3 years
predictors of AF progression3 yearsAF burden by ILR monitoring
complications3 years* tamponade * pulmonary vein stenosis * atrio-esophora fistula (for re-ablation arm) * ventricular arrhythmia * symptomatic bradycardia (for AAD arm)

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026