Atrial Fibrillation Clinical Trial
Official title:
The Effect of Reactive ATP™ on the Burden of Atrial Fibrillation in ICD Patients: The REACT-ICD Trial
Recent advancements with implantable cardiac device technology include extensive diagnostic and therapeutic algorithms for prevention as well as termination of atrial tachyarrhythmias (ATA). Preventive atrial pacing (PAP) and a novel atrial antitachycardia pacing algorithm (Reactive ATP™) in conjunction with managed ventricular pacing (MVP) recently has been shown to reduce progression to permanent atrial fibrillation (AF) in pacemaker patients with intact atriovenous (AV) conduction and a history of ATA. Whether the use of Reactive ATP™ for reducing AF burden extends to patients with an implantable cardioverter defibrillator (ICD), who typically have structural heart disease and heart hailure (HF), is unknown.
Atrial tachyarrhythmias (ATA) and heart failure (HF), which are well-recognized causes of
morbidity and mortality, are growing and concerning issues in our patient population. In
patients implanted with a dual-chamber implantable cardioverter defibrillator (ICD),
progression of paroxysmal to persistent or permanent atrial fibrillation (AF) has been
documented. Because of the untoward consequences of AF, such as development/worsening of HF
or thromboembolic events (stroke and myocardial infarction [MI]), prevention of permanent AF
has the potential to improve quality of life, reduce hospitalizations, and decrease the
complications associated with AF.
Recent advancements with implantable cardiac device technology include extensive diagnostic
and therapeutic algorithms for prevention as well as termination of ATA. Preventive atrial
pacing (PAP) and a novel atrial antitachycardia pacing algorithm (Reactive ATP™) in
conjunction with managed ventricular pacing (MVP) recently has been shown to reduce
progression to permanent AF in pacemaker patients with intact atriovenous (AV) conduction
and a history of ATA. Results of that study suggested that Reactive ATP™ specifically was
responsible for this effect. Whether the use of Reactive ATP™ for reducing AF burden extends
to patients with an implantable cardioverter defibrillator (ICD), who typically have
structural heart disease and HF, is unknown.
The aim of this study is to evaluate the effectiveness of atrial antitachycardia pacing
(Reactive ATP) in patients implanted with either a dual-chamber or cardiac resynchronization
therapy (CRT) ICD who have a history of ATA.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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