REPEATED I.V. BOLUSES FLECAINIDE FOR ACUTE ATRIAL FIBRILLATION TERMINATION A SINGLE BLIND RANDOMIZED REGIMEN CONTROLLED TRIAL. - ND

• Conditions: ATRIAL FIBRILLATION; MedDRA version: 9.1Level: LLTClassification code 10003658Term: Atrial fibrillation

• Registration Number: EUCTR2007-000204-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE DI CIRCOLO A.O. DI RILIEVO REGIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

PATIENTS WITH STABLE FOR AL LEAST ONE HOUR ACUTE AF 48 HOURS DURATION AND WITH VENTRICULAR RESPONSE RATE 70 BPM,WHOSE AGE RANGES FROM 18 TO 90 YEARS, PRESENTING TO THE EMERGENCY ROOM OR ARE ADMITTED IN A CARDIOLOGY ON NON-CARDIOLOGY DEPARTMENT.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

CONGESTIVE HEART FAILURE - AMI ACUTE MYOCARDIAL INFARCTION - ARTERIAL HYPOTENSION BLOOD PRESSURE 100 MM OF HG - KNOWN OR CLINICALLY APPARENT MITRAL STENOSIS - HISTORY OF MYCARDIAL ISCHEMIA - ELECTROLYTE IMBALANCES - SIGNIFICANT HEPATIC OR RENAL DISEASE LIVER ENZYMES ALT OR AST AT LEAST TWICE NORMAL UPPER LIMITS OR CREATININE GREATER THAN TWO MG/DL - ACIDOSIS - SUSPECT OF PULMONARY EMBOLISM - PREGNANCY - PREVIOUS BIFASCICULAR BLOCK LBBB OR RBBB LPH IF MEAN HEART 120 BPM.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified