Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement

Exclusion Criteria

• •Permanent AF defined as continuous AF for 6 months or longer;
• •Persistent AF defined as sustained AF \>7 days duration and/or requiring cardioversion in the 4 weeks before screening;
• •Prior valvular heart surgery or significant valvular heart disease including rheumatic heart disease or acquired valvular heart disease;
• •Aortic or mitral regurgitation greater than mild (\>1+) or any degree of mitral stenosis at the screening echocardiogram;
• •Myocardial infarction within the 6 months prior to screening or stroke within 2 months prior to screening;
• •Pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy devices placed within the 6 months prior to screening or at anytime during the study;
• •Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, syncope as judged by the Investigator;
• •Cardiac ablative procedure or cardiac surgery within 3 months prior to screening, or percutaneous coronary intervention within 4 weeks prior to screening;
• •Need for concomitant medication that is prohibited in this trial, and would preclude the use of the study drug during the planned study period including the following:
• •* Antiarrhythmics (eg, amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol);
• •* Drugs or products that are strong inhibitors of CYP3A (eg, ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir, and grapefruit juice);
• •* Drugs that are inducers of CYP3A (eg, rifampin, phenobarbital, carbamazepine, phenytoin, and St John's wort);
• •QTc Bazett interval ≥500 msec on the screening ECG;
• •Bradycardia \<50 bpm and/or PR interval ≥0.28 sec on the screening ECG unless the patient has a functional pacemaker;
• •New York Heart Association (NYHA) Class IV heart failure or NYHA Class II or III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to screening.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.