Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
Brief Summary: The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.


Options:
A: Inclusion Criteria:

1. Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead) with remote monitoring capabilities and EF \<= 40% within the last 3 months by echocardiogram, nuclear imaging, MRI or cardiac catheterization,
2. Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration at least once per month.
3. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy
4. Ability to complete 6 minute walk test.
5. Age \>= 18 years old. (Females must be either post-menopausal \>12 months, practicing a protocol-acceptable method of birth control \[defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide\], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment).
6. All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker.
7. patients receiving low dose amiodarone- \<200 mg for 2 or less months

Exclusion Criteria:

The exclusion criteria are:

1. Reversible causes of AF such as pericarditis, hyperthyroidism,
2. Presently with Valvular Heart disease requiring surgical intervention
3. Presently with coronary artery disease requiring surgical intervention
4. Early Post-operative AF (within three months of surgery)
5. Previous MAZE or left atrial instrumentation
6. Prolonged QT interval
7. Hypothyroidism
8. Liver Failure
9. Life expectancy \<= 2 years
10. Social factors that would preclude follow up or make compliance difficult.
11. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
12. Enrollment in another investigational drug or device study.
13. Patients with severe pulmonary disease i.e. COPD or asthma
14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
15. Any ophthalmologic disorders (other than requiring glasses for vision correction)
B: Inclusion Criteria:

* 1. Patients aged 75 years or older (70 years before protocol amendment 1), or patients aged at least 70 years (any age before protocol amendment 1) with one or more of the following risk factors at baseline:

  * Hypertension (taking antihypertensive drugs of at least two different classes)
  * Diabetes
  * Prior cerebrovascular accident (stroke or transient ischemic attack) or systemic embolism
  * Left atrium diameter greater than or equal to 50 mm by echocardiography
  * Left ventricular ejection fraction less than 0.40 by 2D-echocardiography (two-dimensional echocardiography)
* 2. Availability of one electrocardiogram (ECG) within the last 6 months, showing that the patient was or is in AF/AFL
* 3. Availability of one ECG within the last 6 months, showing that the patient was or is in sinus rhythm

Exclusion Criteria:

General criteria:

* 1. Refusal or inability to give informed consent to participate in the study
* 2. Any non cardiovascular illness or disorder that could preclude participation or severely limit survival including cancer with metastasis and organ transplantation requiring immune suppression
* 3. Pregnant women (pregnancy test must be negative) or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception \[oral contraception or intra-uterine device (IUD)\] or sterile can be randomized.
* 4. Breastfeeding women
* 5. Previous (2 preceding months) or current participation in another clinical trial with an investigational drug (under development) or with an investigational device
* 6. Previous participation in this trial

Criteria Related to a cardiac condition:

* 7. Patients in permanent atrial fibrillation
* 8. Patients in unstable hemodynamic condition such as acute pulmonary edema within 12 hours prior to start of study medication; cardiogenic shock; treatment with intra-venous pressor agents; patients on respirator; congestive heart failure of stage NYHA IV (New York Heart Association classification) within the last 4 weeks; uncorrected, hemodynamically significant primary obstructive valvular disease; hemodynamically significant obstructive cardiomyopathy; a cardiac operation or revascularization procedure within 4 weeks preceding randomization
* 9. Planned major non-cardiac or cardiac surgery or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG) , percutaneous coronary intervention (PCI) , or on urgent cardiac transplantation list
* 10. Acute myocarditis or constrictive pericarditis
* 11. Bradycardia \< 50 bpm and/or PR-interval \> 0.28 sec on the last 12-lead ECG
* 12. Significant sinus node disease (documented pause of 3 seconds or more) or 2nd or 3rd degree atrioventricular block (AV-block) unless treated with a pacemaker

Criteria Related to Concomitant Medications:

* 13. Need of a concomitant medication that is prohibited in this trial, including the requirement for Vaughan Williams Class I and III anti-arrhythmic drugs, that would preclude the use of study drug during the planned study period

Criteria Related to Laboratory Abnormalities:

* 14. Plasma potassium \< 3.5 mmol/l (as anti-arrhythmic drugs can be arrhythmogenic in patients with hypokalemia, this must be corrected prior to randomization)
* 15. A calculated Glomerular Filtration Rate (GFR) at baseline \<10 ml/min using the Cockroft Gault formula
C: Inclusion Criteria:

* Patients aged 21 years or more of either sex with documented sinus rhythm for at least 1 hour at the time of randomization with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion Criteria:

* MAIN CRITERIA (non-exhaustive list):Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, contraindications to amiodarone, conditions which increase the risk of severe antiarrhythmic drug side effects, severe left ventricular dysfunction, severe associated conditions.
D: Inclusion Criteria:

* Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation

Exclusion Criteria:

* Contraindication to oral anticoagulation
* Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous)
* Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
* Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
* History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
* Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
* Dysthyroidism or other contraindication to amiodarone

The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.

Answer: D