The REACT-ICD Trial

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Atrial Tachyarrhythmia, Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT02439424

Run by

Hartford Hospital

People needed

6

Starts

2015-12-01

Expected to finish

2017-03-01

Last updated by the study team

2016-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• male and female patients
• ≥18 years old (no upper age limit)
• previously implanted with a Medtronic dual-chamber or CRT ICD with capability of atrial antitachycardia pacing; specifically, Reactive ATP™ at least 9 months previously (six months data collection and implant occurring at least 3 months previously to allow healing and establishment of stable sensing)
• measured P wave in sinus rhythm of at least 0.8 mV
• >=6 months AT/AF burden data available, either from CareLink® or in-office interrogation
• >=1.0% AT/AF burden (hours in atrial fibrillation/total hours monitored) in the last 6 months
• No change in antiarrhythmic drug therapy (Vaughan-Williams class I or III) in the last 6 months

You may not qualify if…

• Persistent or permanent AT/AF (AF burden >95%)
• Cardioversion for atrial fibrillation or atrial flutter within the last 6 months, either intentional or as a result of a tachyarrhythmia therapy
• Ablation for atrial fibrillation or atrial flutter within the last 9 months (6 months data collection following a 3 month blanking period post procedure)
• Reactive ATP™ previously programmed on
• Measured P waves in sinus rhythm consistently <0.8 mV on repeat measurements.
• Unresolved artifactual AT/AF detection due to far-field R wave or other oversensing
• Expected generator change or other device surgery within six months

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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