Cardiac Electrophysiological Study

AstraZeneca55 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atrial Flutter

Interventions

AZD1305DRUG

Intravenous infusion

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (13)

Research Site

Aalborg, Denmark

Research Site

Aarhus, Denmark

Research Site

Copenhagen, Denmark

Research Site

Hellerup, Denmark

Outcomes

Primary Outcomes

LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))

Absolute change, after - before infusion

Time frame: 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 Outcomes

RAERP (Right Atrial Effective Refractory Period)

Absolute change, after - before infusion

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: During and after infusion

Data from ClinicalTrials.gov

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