Reversal of Atrial Substrate to Prevent Atrial Fibrillation Pilot Study
Reversal of Atrial Substrate to Prevent Atrial Fibrillation 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.
Inclusion Criteria:

 -  Patients with symptomatic (CCS-SAF ≥2) recurrent paroxysmal or persistent nonvalvular
 atrial fibrillation despite rate control, desiring catheter ablation AND

 -  one of : BMI>27, BP>140/90 or history of hypertension, alcohol use > recommended
 limit, current smoking, diabetes with HgA1C>7%, physical inactivity (<150
 minutes/week).

 (Definitions: Recurrent paroxysmal - at least 4 episodes of symptomatic AF in the prior 6
 months, with or without cardioversion; Persistent AF lasting greater than 7 days but less
 than 3 years; AF must be documented on a Holter, rhythm strip or electrocardiogram within
 the last 24 months.)

 Exclusion Criteria:

 -  Permanent AF (AF lasting > 3 years)

 -  Prior catheter ablation for AF

 -  Left ventricular ejection fraction <30%

 -  Left atrial size > 5.5 cm

 -  NYHA IV heart failure

 -  Participation in a cardiac rehabilitation program within the last year

 -  Currently performing exercise training 150 minutes/week of moderate to vigorous
 physical activity

 -  Unable to exercise

 -  Unable to give informed consent

 -  Other noncardiovascular medical condition making 1 year survival unlikely