Cardiac Electrophysiological Study

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

Official Title
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A Multi-centre, Double-blind, Randomised, Placebo-controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure

Conditions
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Atrial Flutter

Intervention / Treatment
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* Drug: AZD1305


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD1305|Intravenous infusion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAERP (Right Atrial Effective Refractory Period) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product | 
| VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product | 
| QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds) | Absolute change, after - before infusion | Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona | 
| Cmax Observed for AZD1305 | A total of 13 scheduled PK samples for each patient during and after infusion | During and after infusion | 
| AUC Total of AZD1305 (Umol*h/L) | A total of 13 scheduled PK samples for each patient during and after infusion | Based on PK samples during and after infusion | 
| Number of Patients Who Had at Least One AE | Number of patients | During active treatment period |