Atrial Fibrillation
Conditions
Keywords
Pacing dependent, Atrial Fibrillation, Amiodarone, Propafenone, Sotalol, AF burden
Brief summary
The current evidences indicate that \ 30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.
Interventions
DRUGAmiodarone
Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
DRUGPropafenone
150mg per 8 hours, 3 times per day
DRUGSotalol
80mg twice per day.
Sponsors
Medtronic (Shanghai) Management Co. Ltd.
Beijing CTSmed Co. Ltd
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
* at least 18 years old * sick sinus syndrome with pacemaker Class I or Class IIa indication * has a pacemaker which can provide the daily AF burden monitor record for at least 28 days * has at AF record in the past 6 months, the valid AF record includes any of 1. at least one 30 seconds AF holter record 2. at least one 15 seconds 12-ECG record 3. at least 5 minutes long AF episodes record from pacemakers * able and willing to give informed consent
Exclusion criteria
* will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation * NYHA Class III or IV * LVEF \<50% * Reversible AF, such as AF caused by hyperthyroidism or severe postoperative atrial fibrillation * Persistence AF * Expected life expectancy less than 1 year * Planned to be pregnant or be in the feeding period in the next year * Non-stable, decompensated heart failure * Allergy to Amiodarone, Propafenone or Sotalol * Cancer * Clear liver damage ( ALT and/or AST \> 2\*normal limit) * Patients with cardiogenic shock history * Be in the treatment of Amiodarone for more than 3 months or less than 3 months with Amiodarone wash out period less than 30 days * Coronary artery disease (CHD), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (COPD), long QT syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average AF burden in minutes per day | monthly up to 12 months | Long term usages of test drug reduce AF burden, including the number and accumulated total time of AF per day. |
| Persistent AF free survival rate | monthly up to12 months | Long term usages of test drugs reduce the occurence of the persistent AF ( the persistent AF survival rate)。 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular function | 0months, 6months and 12 months | LVEF(Simpson), LV volume, diastolic function (E/A ), tricuspid regurgitation, Left atrial size and volume |
| SF-36 health survey | 0 months, 6 months and 12 months | SF-36 health survey |
| comorbidity and mortality | 6 months and 12 months | The rate of stroke, infarction, heart failure, rehospitalization and cardiovascular and total mortality rate. |
Countries
China
Contacts
Primary ContactYi-Gang Li, MD
Backup ContactBo Liu, MD
Outcome results
None listed