Please select the eligibility criteria that correspond to the clinical trial below.
Title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter
Brief Summary: Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.


Options:
A: Inclusion Criteria:

* Symptomatic paroxysmal or persistent atrial fibrillation
* Failure or intolerance of antiarrhythmic drug therapy or unwillingness to take antiarrhythmic drugs
* Left Ventricular Ejection Fraction \<= 35%
* NYHA \>= II
* ICD for primary or secondary prevention with atrial sensing capabilities or Cardiac Resynchronization Therapy plus Defibrillator (CRT-D) device, both with Home Monitoring® technology already implanted
* Patient is willing and able to comply with the protocol and has written informed consent
* Age \>= 18 years

Exclusion Criteria:

* Contraindication for chronic anticoagulation therapy and heparin
* Documented left atrial diameter \> 6 cm
* Previous left heart ablation procedure for atrial fibrillation
* Acute coronary syndrome, cardiac surgery, angioplasty or stroke within 2 months prior to enrollment
* Untreated hypothyroidism or hyperthyroidism
* Enrollment in another investigational drug or device study
* Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age
* Mental or physical inability to take part in the study
* Listed for heart transplant
* Cardiac assist device implanted
* Planned cardiovascular intervention
* Life expectancy ≤ 12 months
* Uncontrolled hypertension
* Requirement for dialysis due to terminal renal failure
* Participation in another telemonitoring concept
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 of either sex aged 21 years or more, in sinus rhythm for at least 1 hour at the time of randomisation and with at least one ECG-documented AF/AFL episode in the last 3 months.

Exclusion Criteria:

* MAIN CRITERIA (non-exhaustive list, see protocol for details):

Women of childbearing potential without adequate birth control, Pregnant women, Breastfeeding women, Congestive heart failure NYHA class III or IV, Conditions which increase the risk of severe antiarrhythmic drug side effects, Severe associated conditions.
D: Inclusion Criteria:

* AF/AFL for \>72 hours and documented by 2 12-lead ECGs separated by at least 72 hours and indication for electrical cardioversion of the current AF/AFL episode as judged by the investigator.

Exclusion Criteria:

MAIN CRITERIA (non-exhaustive list):

* Women of childbearing potential without adequate birthcontrol, Pregnant Women, Breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, permanent pacemaker, permanent AF/AFL, contraindication to anticoagulant, severe left ventricular dysfunction, severe associated conditions.

Answer: D