Overview

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

Status:
Terminated

Trial end date:
2018-05-04

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

GE Healthcare

Collaborators:

ABX CRO
Advanced Clinical, LLC
AG Mednet Inc.
H2O Clinical LLC
ICON CEAC
ICON Clinical
ICON plc
TFS
TFS Trial Form Support
TransPerfect

Treatments:

3-Iodobenzylguanidine
Lugol's solution