Atrial Fibrillation Clinical Trial
Official title:
Use of a High Density Mapping System to Complete Wide Area Circumferential Ablation of the Pulmonary Veins and Avoid Ostial Segmental Ablation
This is a prospective, multicentre, randomized single blind, parallel group study to be conducted in the UK (2 sites).Approximately 48 patients will be recruited aiming for 40 eligible for randomization. The study is designed to compare the operator's best attempt at WACA completion with and without Rhythmia guidance
BACKGROUND Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia occurring
in 1-2% of the general population. AF can be associated with debilitating symptoms and
confers an increased risk of death, stroke, heart failure and hospitalization. As such there
is a need for effective therapies for AF. In particularly catheter based therapies, which can
limit the need for chronic drug therapy, are becoming more widely accepted.
The development of AF requires both a trigger and susceptible substrate. Ectopic activity
originating within the pulmonary veins (PVs) is a widely recognised factor in the genesis of
paroxysmal AF, whilst electrical, contractile and structural remodelling of atrial myocardium
are each important contributing factors to the arrhythmogenic substrate in AF.
An early strategy in paroxysmal AF (PAF) was to target ectopic triggers coming from the PV
via ostial segmental ablation (OSA). Here radiofrequency (RF) ablation was applied close to
the PV ostia at sites of early signals, usually until PVs were electrically isolated from the
left atrium (LA). This approach resulted in a success rate, with regard to freedom from AF
after a single procedure, of 65-90% after 1 year but closer to 50% after 5 years. The
recognition of PV stenosis as a complication of RF delivery within a PV, as well as the
recognition that initiation sites could be located in the antrum led to a shift in ablation
strategy towards wider encirclement of the PVs using wide area circumferential ablation
(WACA) using electroanatomical mapping to guide RF delivery. This resulted in improved
success rates in a head-to-head comparison with OSA and it is possible that this relates to
substrate modification inherent in this approach.
Recurrence of AF remains problematic following ablation. Pulmonary vein reconnection after
ablation is thought to contribute to the majority of recurrent episodes of AF in paroxysmal
AF. Electrical isolation of the PVs is often not achievable with WACA alone - 95% of patients
had residual connections following WACA alone in one study. Most clinicians at this juncture
will look for any obvious gaps in the line and ablate if there are early PV signals. If this
is unsuccessful then it is often necessary to resort to OSA to achieve PV isolation. In
essence a large proportion of PV isolation procedures, which started with a WACA strategy,
are in fact a hybrid of WACA and OSA. This both has the potential to increase the
complication rate by risking PV stenosis and reducing efficacy through omitting important
substrate modification and allowing residual connection of part of the antrum and the LA.
The introduction of Rhythmia, a novel electroanatomical mapping system with the potential to
rapidly acquire high density electroanatomical data, may allow an alternative strategy and
more efficient targeting of gaps in WACA lines. The pilot data shows that the system is
particularly adept in assessing gaps in ablation lines including WACA lines. Mapping and
targeting such gaps may hold the key to efficiently completing PV isolation after an initial
WACA line is performed.
RATIONALE FOR CURRENT STUDY Research Question: Can ostial segmental ablation be avoided
during a wide area circumferential ablation (WACA) by using the Rhythmia high density mapping
system? Hypothesis: The current study is designed to test the hypothesis that high density
mapping using Rhythmia can enhance the operator's ability to electrically isolate PVs without
unnecessary excessive ablation or OSA
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