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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
395
Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.
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.
Participants received a thyroid blocking agent before the Iobenguane I-123 Injection, AdreView, scan unless medically not indicated, according to local practice.
Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.
All participants allocated to the SoC (control) group underwent ICD implantation.
Vascular Biology and Hypertension Program, University of Alabama at Birmingham
Birmingham, Alabama, United States
Comprehensive Cardiovascular Medical Group
Bakersfield, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, United States
All-cause Mortality
All-cause mortality included all reported deaths of participants during the study due to any cause. Percentage of participants who died due to any cause were reported.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set
Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device' for participants with H/M \>=1.6. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Cardiac Death
Cardiac death composed of sudden cardiac death, death due to cardiac arrhythmia, death due to heart failure, and death due to other cardiovascular causes.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Hospitalization for Cardiovascular Cause
Percentage of participants who were hospitalized for cardiovascular cause were reported.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With All-Cause Hospitalization
Percentage of participants with all-cause hospitalization were reported.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Events (Composite of the Occurrence of Resuscitated Life-Threatening Ventricular Tachycardia, Unstable Ventricular Tachyarrhythmias, Sudden Cardiac Death [SCD] and Resuscitated Cardiac Arrest)
Percentage of participants with composite events i.e occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest were reported. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Syncope
Percentage of participants with Syncope were reported. Participants who were alive at time of DBL were censored at the last known-alive date by date of DBL.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Implantable Cardioverter Defibrillator (ICD) Implantation
Percentage of participants with ICD implantation were reported.
Time frame: From randomization until the end of the follow-up period (median 304 days)
Percentage of Participants With Events of Complications of Device
Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device'.
Time frame: From randomization until the end of the follow-up period (median 304 days)
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Cardiology Physicians PA/Red Clay Research, LLC
Newark, Delaware, United States
Bethesda Health
Boynton Beach, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Cardiology Consultants
Pensacola, Florida, United States
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