drugset / Trial / NCT02656329

International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device

NCT02656329

RandomizedParallel-groupOpen-labelPrevention

Summary

This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure participants with 25%\<=left ventricular ejection fraction (LVEF)\<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

Timeline

Start
2015-12-30
Primary completion
2018-05-04
Completion
2018-05-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Iobenguane I-123 Injection Diagnostic / imaging agent 370 mbq Intravenous
Background Lugol's Solution Unknown
Background potassium iodide Unknown

Indications