A multi-centre study comparing the effects of AZD2927 and placebo on the electrical activity in the heart in patients undergoing treatment for atrial flutter

Phase 1

• Conditions: Arrhythmia; MedDRA version: 14.0Level: PTClassification code 10003119Term: ArrhythmiaSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001716-59-NO
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-08
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

*Male or postmenopausal female, aged 20 to 80 years inclusive
*Clinical indication for catheter ablation of atrial flutter
*History of paroxysmal atrial flutter, with or without paroxysmal AF. *Single episodes of persistent atrial flutter or AF requiring cardioversion do not exclude the patient from the study.
*Sinus rhythm at randomisation
*Adequate anticoagulation or antithrombotic treatment according to ESC guidelines 2010 or national guideline.
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 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

*Cardioversion within (=)14 days before randomisation
*History of stroke or transient ischaemic attack (TIA). History of significant head trauma, epilepsy or other disorders increasing the risk for seizures.
*QTcF >450 ms or <350 ms measured in sinus rhythm at randomisation
*History and/or signs of clinically significant sinus node dysfunction. Sinus bradycardia =50 beats per minute (bpm) at randomisation
*Personal or family history of Torsades de Pointes (TdP), any other polymorphic ventricular tachycardia, long QT syndrome, short QT syndrome, Brugada syndrome, or personal history of sustained (>30 s) monomorphic ventricular tachycardia

Study & Design

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