Cardiac Electrophysiological Study

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Atrial Flutter

Treatments: Drug: AZD1305

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616629

D3190C00005

2007-0003455-36 (EudraCT No)

Details and patient eligibility

About

The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures

Enrollment: 55 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with atrial flutter (with a ventricular rate of <100 beats/minute at enrolment), scheduled for curative catheter ablation
• Sinus rhythm at randomisation

Exclusion criteria

• QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
• Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
• QRS duration >120 ms at randomisation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind