Atrial Fibrillation Clinical Trial
Official title:
Outcome of Different Ablation Strategies In Persistent and Long-Standing Persistent Atrial Fibrillation
Specific Aim: This prospective randomized study aims to compare the impact of three different catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial electrograms (CFAE).
Specific Aim: This prospective randomized study aims to compare the impact of three different
catheter ablation approaches on long-term procedure outcome in terms of arrhythmia recurrence
in persistent (PeAF) and long-standing persistent atrial fibrillation (LSPAF) patients. The
three strategies to be evaluated are 1) ablation at sources guided by FIRMap (using
RhythmView™ Workstation from TOPERA), 2) ablation at sources guided by FIRMap + conventional
pulmonary vein antrum isolation (PVAI) and 3) Extended PVAI plus ablation of non-PV triggers
and complex fractionated atrial electrograms (CFAE).
Hypothesis: Extended PVAI plus ablation of non-PV triggers and CFAE results in better
long-term procedure outcome in PeAF and LSPAF patients.
Background: The limited success rate of conventional ablation approaches in LSPAF has led to
the search for the ideal ablation strategy (1). The main problem in the settings of PeAF and
LSPAF is the lack of information on the best targets to ablate to achieve freedom from
arrhythmia (2). Some strategies aim at elimination of AF triggers; some solely target CFAE
for atrial substrate modification whereas others elect for isolation of PVs plus posterior
wall along with ablation of non-PV triggers demonstrated by high-dose isoproterenol challenge
with or without CFAEs. (2). The last option has been shown to be the best option so far in
improving the freedom from AF at long-term follow-up (2, 3).
Recently Narayan et al, by using a computational mapping system that identifies 'rotors'
(organized reentrant circuits or focal impulses), were able to achieve a success rate of
82.4% following ablation of rotors plus PVAI, at a median follow-up of 273 days, in a
primarily paroxysmal AF population (4). The results of this study are promising and need to
be tested in patients with PeAF and LSPAF.
Objective: To compare the long-term efficacy and safety of different ablation approaches in
PeAF and LSPAF patients.
Study Design: This prospective study will enroll 120 consecutive PeAF/LSPAF patients and
consenting patients will be randomized to any of the 3 groups (40 per group); Group 1:
ablation at sources guided by FIRMap (using RhythmView™ Workstation from TOPERA) Group 2:
ablation at sources guided by FIRMap + conventional pulmonary vein antrum isolation (PVAI)
Group 3: Extended PVAI plus ablation of non-PV triggers and complex fractionated atrial
electrograms (CFAE) Patients will be randomized to different treatment groups after the risks
and benefits of each one are discussed in detail with them.
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