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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- progression of AF (AF burden progression and persistent AF)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone) (Drug)
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.
Intervention: ILR implantation (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. 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: re-ablation procedure (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. 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: ILR implantation (Procedure)
Outcomes
Primary Outcomes
progression of AF (AF burden progression and persistent AF)
Time Frame: 3 year
Secondary Outcomes
- 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)