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
Phase 3
Terminated
395 enrolled
GE Healthcare
ABX CRO · collabAG Mednet · collabAdvanced Clinical, LLC · collabH2O Clinical LLC · collabICON plc · collabTFS · collabTransPerfect · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iobenguane I-123 Injection | Diagnostic / imaging agent | 370 mbq | Intravenous |
| Background | Lugol's Solution | Unknown | — | — |
| Background | potassium iodide | Unknown | — | — |