Atrial Fibrillation
Conditions
Brief summary
Randomized trial of low-dose amiodarone therapy versus catheter ablation (CA) in older patients with persistent atrial fibrillation (AF). Primary Objective: To compare amiodarone to catheter ablation in patients aged 50 to 80 years with symptomatic AF for the composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia
Detailed description
This is a single centre vanguard phase prospective randomized open label study with blinded outcome adjudication. Patients will be randomized by a central randomization system (1:1) to amiodarone or catheter ablation. 1. Amiodarone will be started at a dose of 400 mg/day. After one month the dose will be lowered to 200 mg per day. Patients will be seen every six months. At each visit the dose of amiodarone will be lowered by 100 mg per week if the patient is having a good clinical response to treatment. Good clinical response will be a a clinical assessment that takes into account not only actual or possible arrhythmia recurrence but also side-effects and patient acceptability of treatment. A minimum dose of 700 mg/week will be allowed. If patient symptoms recur, the amiodarone dose may be increased but not above a dose of 200 mg/day . 2. Catheter ablation of persistent AF will be done within two months using pulmonary vein isolation in all subjects 3. Patient not in sinus rhythm at time randomization will undergo DC cardioversion after at least 1 month of amiodarone Rx or during CA. Follow up: Clinical assessment will include a medical history and physical examination to be performed at baseline, and every 3 months. This will also include 12-lead ECG. b. At 3, 6, 12, 18, and 24 months: QOL questionnaire (AFEQT- Atrial Fibrillation Effect on QualiTy of life) c. Thyroid and liver function tests, chest X-ray will be obtained at regular intervals. d. Arrhythmia will be monitored using a 2-week event monitors at 6, 12, 18, 24 months.
Interventions
PROCEDURECatheter ablation
Pulmonary vein isolation by catheter ablation
DRUGAmiodarone
antiarrhythmic therapy using Amiodarone
Sponsors
Hamilton Health Sciences Corporation
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Recurrent symptomatic Atrial Fibrillation (AF) 2. Age 50-80 years with persistent AF (≥1 of AF episode lasting more than a week or requiring cardioversion)
Exclusion criteria
1. Permanent atrial fibrillation 2. Prior continuous use of amiodarone of more than 2 weeks. 3. Prior catheter ablation for AF. 4. Have a documented resting heart (while awake) of \< 50 beats per minute. 5. Have a known severe liver disease. 6. Are deemed not suitable for CA (LA size, comorbidities…). 7. Have a severe valvular disease or have a mechanical mitral prosthesis. 8. Have a life-expectancy of less than 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite outcome of hospitalization for cardiovascular cause or emergency department visit for atrial arrhythmia. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| First recurrence of an atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor | 2 years |
| First recurrence of a symptomatic atrial tachyarrhythmia documented on 12 lead ECG or a 14-day event monitor | 2 years |
| Quality of life measured at 3, 6 and 12 months using the Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) | 2 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| Potential Side Effects Related to amiodarone or ablation procedure | 2 years | Known potential side effects of catheter ablation include vascular access complications such as hematoma, pseudoaneurysm, or AV fistula. Less common but more serious include cardiac perforation (0.5%-1%) and thromboembolism (0.5%-1%), and fatal complications occur in approximately 1:1000 cases. Known potential side effects of amiodarone include amiodarone toxicity, corneal micro-deposits, photosensitivity, thyroid abnormalities. pulmonary toxicity, abnormal liver function, and skin discolouration. |
Countries
Canada
Outcome results
None listed