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

AdreView™ Myocardial Imaging for Risk Evaluation - A Multicentre Trial to Guide ICD Implantation in NYHA Class II & III Heart Failure Patients With 25%≤LVEF≤35%

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Iobenguane I -123 Injection	Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.
DEVICE	Implantable Cardioverter Defibrillator	In the Iobenguane I-123 Injection group, participants with H/M ratio less or equal to 1.6 underwent ICD device implantation, while those with H/M ratio greater than or equal to 1.6 did not undergo ICD implantation.
DRUG	Thyroid blocking	Participants received a thyroid blocking agent before the Iobenguane I-123 Injection, AdreView, scan unless medically not indicated, according to local practice.
DRUG	Iobenguane I -123 Injection	Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.
DEVICE	Implantable Cardioverter Defibrillator	All participants allocated to the SoC (control) group underwent ICD implantation.

Timeline

• Start date: 2015-12-30
• Primary completion: 2018-05-04
• Completion: 2018-05-04
• First posted: 2016-01-14
• Last updated: 2019-05-22
• Results posted: 2019-05-22

Locations

94 sites across 10 countries: United States, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Spain