A Phase 1/2 interventional study of Reactive ATP in Atrial Tachyarrhythmia and Atrial Fibrillation, sponsored by Hartford Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-23.
Sponsored by Hartford Hospital · Phase 1/2, Interventional, and Health services research
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 6 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
all enrolled subjects will have the Reactive ATP feature in their ICD turned "on"
Device: Reactive ATP
Reactive ATP turned to "on"
atrial fibrillation burden
% of time in atrial fibrillation = time in atrial fibrillation (over 6 months of study) / 6 months
Time frame: 6 months
Persistent/permanent atrial fibrillation
number/percentage of patients in persistent (7 days) or permanent atrial fibrillation
Time frame: 6 months
cardioversion
number/percentage of patients who underwent cardioversion
Time frame: 6 months
cardiovascular hospitalization
number/percentage of patients who were hospitalized for cardiac-related issues
Time frame: 6 months
percentage of ventricular pacing
percentage of ventricular beats that are paced by the ICD
Time frame: 6 months
Ventricular tachycardia/Ventricular fibribilation ICD therapies
number of appropriate or inappropriate therapies (ATP \[antitachycardiac pacing\] or shock)
Time frame: 6 months
This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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