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

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

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.

Sponsors & Collaborators

• Advanced Clinical, LLC

  collaborator UNKNOWN

• TFS

  collaborator UNKNOWN

• H2O Clinical LLC

  collaborator INDUSTRY

• AG Mednet Inc.

  collaborator UNKNOWN

• ICON CEAC

  collaborator UNKNOWN

• ICON Clinical

  collaborator UNKNOWN

• ABX CRO

  collaborator OTHER

• TransPerfect

  collaborator INDUSTRY

• GE Healthcare

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-12-30

Primary Completion

2018-05-04

Completion

2018-05-04

Countries

• United States
• Canada
• Czechia
• France
• Germany
• Hungary
• Italy
• Netherlands
• Poland
• Spain

Study Locations