Clinical trial NCT02145546: Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
Official title: Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Pacing dependent
Atrial Fibrillation
Amiodarone
Propafenone
Sotalol
AF burden
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Medtronic (Shanghai) Management Co. Ltd.
name: Beijing CTSmed Co. Ltd
First posted: 2014-05-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average AF burden in minutes per day
timeFrame: monthly up to 12 months
measure: Persistent AF free survival rate
timeFrame: monthly up to12 months
Secondary outcomes:
measure: Left ventricular function
timeFrame: 0months, 6months and 12 months
measure: SF-36 health survey
timeFrame: 0 months, 6 months and 12 months
measure: comorbidity and mortality
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicne
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiaotong University School of Medicne
name: Yi-Gang Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: OSTRANDER LD Jr, BRANDT RL, KJELSBERG MO, EPSTEIN FH. ELECTROCARDIOGRAPHIC FINDINGS AMONG THE ADULT POPULATION OF A TOTAL NATURAL COMMUNITY, TECUMSEH, MICHIGAN. Circulation. 1965 Jun;31:888-98. doi: 10.1161/01.cir.31.6.888. No abstract available.
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citation: Nowak B, McMeekin J, Knops M, Wille B, Schroder E, Moro C, Oelher M, Castellanos E, Coutu B, Petersen B, Pfeil W, Kreuzer J; Stored EGM in PulsarMax II and Discovery II Study Group. Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms. Pacing Clin Electrophysiol. 2005 Jul;28(7):620-9. doi: 10.1111/j.1540-8159.2005.00159.x.
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