Atrial Fibrillation Clinical Trial
Official title:
Reversal of Atrial Substrate to Prevent Atrial Fibrillation - A Pilot Study
This is a pilot study to assess feasibility to conduct a multi-center, randomized trial to examine the effect of aggressive risk factor control and arrhythmia trigger-based intervention on the atrial substrate, which is involved in the development and maintenance of atrial fibrillation (AF).
Atrial fibrillation (AF) is a major health problem, with a prevalence of 0.4-1% of the
population. It is associated with a six-fold risk of stroke and a two-fold increase in
mortality, the main cardiac reason for death one year after presenting to the emergency
department with AF is heart failure. It results in high healthcare costs, recurrent ED visits
and hospitalizations. The burden of disability associated with AF has been found to increase
by 20% from 1990-2010. AF was also cited as one of the seven causes of death that has been
increasing worldwide. Prevention of AF has not been a focus of past treatments and it is well
known that elevated body mass index, hypertension, smoking, increased alcohol intake, lack of
exercise and sleep apnea are risk factors for AF. There is a lack of randomized, multicenter
data proving that a strategy of aggressive risk factor modification will prevent and modify
AF.
Upstream therapy for AF has been of considerable interest, and benefit has been demonstrated
in primary prevention of AF. Catheter ablation has demonstrated success over current medical
therapies for long-term rhythm control, but recurrence remains high, irrespective of ablation
strategy. This study is a feasibility study to determine whether a complex and
multi-component risk factor modification can be successfully implemented.
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