Persistent Atrial Fibrillation
Conditions
Keywords
persistent atrial fibrillation, amiodarone, late recurrence atrial fibrillation, adverse events
Brief summary
Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.
Interventions
DRUGwithdrawal or continuation of amiodarone therapy
withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy
Sponsors
University Medical Center Groningen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* history of persistent atrial fibrillation, necessitating at least one electrical cardioversion * presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone * clinically stable * age \> 18 years * written informed consent
Exclusion criteria
* sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason) * symptomatic heart failure NYHA III or IV * unstable angina pectoris * hemodynamically significant valvular disease * concomitant treatment with other class I or III antiarrhythmic drug * PCI,CABG, other cardiac surgery or major non-cardiac surgery within the last three months * recent myocardial infarction (\< 3 months) * presence of any disease that is likely to shorten life expectancy to \< 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| occurrence of late relapse of persistent atrial fibrillation | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies | 2 years |
Countries
Netherlands
Outcome results
None listed