A Randomized Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients with a Documented First Episode of Atrial Fibrillation. - FLEC-PO-NA-CACR-06-MC-M

aboratoires 3M Santé0 sites320 target enrollmentDecember 15, 2006

Overview

No summary available.

Registry

who.int

Start Date

December 15, 2006

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

aboratoires 3M Santé

•Subjects are eligible for participation in the study if the following inclusion criteria are met:
•1\. Willing to participate in the study,
•2\. Age between 18 and 65 years,
•3\. Willing to attend 10 outpatient visit during the course of the clinical study and to comply with the study requirements such as willing to undergo at least 8 ECGs, 3 Holters, and at least 2 weekly self ECG unit (heart scan) evaluations
•4\. History of one only symptomatic\* and documented AF episode with duration \> 1h and \< 7 days which occurred during the 5 weeks prior to inclusion visit and terminated spontaneously or with medical treatment.
•(\*This episode should be the first and only one known and documented AF episode”. Symptom(s) should have been present for at least 1hour prior to and during the event record.)
•5\. Patient not on AAD at the time of recruitment
•6\. Patient must be in sinus rhythm at the time of treatment initiation.
•7\. Left ventricular ejection fraction \> 40%, evaluated by a transthoracic echocardiogram, performed at the inclusion visit.
•8\. Females of child bearing potential must have a negative urine pregnancy test at the inclusion visit and at the end of study visits and be willing to use a medically acceptable method of contraception during the study.

•Subjects will be excluded from the study if any of the following apply:
•1\. History of more than one symptomatic documented AF episode
•2\. Persistent or permanent AF.
•3\. History of ablation for previous AF.
•4\. Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery).
•5\. Severe symptoms during AF episode (e.g.syncope, chest pain).
•6\. All types of treated arrhythmias other than AF
•7\. History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association \-NYHA\- classification) or valvular diseases.
•8\. Left ventricular ejection fraction (LVEF) \= 40%,
•9\. Bradycardia \< 40 beats/min and all ECG abnormalities: PR\> 240ms or QRS\> 120 ms or QTc\> 440 ms,