A randomized controlled clinical trial comparing ventricular fibrillation detection time between two transvenous defibrillator models

The Ventak AV is an implantable cardioverter defibrillator with dual chambe r pacing capability. Features include detection and treatment of ventricula r arrhythmias, detection of atrial arrhythmias, as well as dual chamber pac ing, The objective of the investigation was to verify the efficacy of the V entak AV in detecting ventricular fibrillation in the presence of dual cham ber pacing. Thirty-three patients, who: were to receive an implantable defi brillator were randomized (1:1) in a paired comparison study to the Ventak AV (study device) and the Ventak Mini (control) during defibrillation thres hold testing. In order to create a "worst case scenario" for sensing of ven tricular fibrillation, pacing was performed at high lower rate limit values (Ventak AV DDD pacing at 150/min, Ventak Mini at VVI 100/min). Ventricular fibrillation was induced and the randomized device was allowed to detect a nd treat the arrhythmia. This test was repeated or each patient using the a lternate device in a randomized order, such that all patients were tested w ith both devices. The mean ventricular fibrillation detection time for the Ventak AV was 2.0 +/- 0.11 seconds and for the control device the detection time was 1.8 +/- 0.12 seconds (P = 0.26). Appropriate tachyarrhythmia ther apy decision was documented in all episodes for both devices. The study pat ient population demonstrated equivalent ventricular fibrillation detection time between the Ventak AV and the Ventak Mini. The Ventak AV demonstrated effectiveness in detecting ventricular fibrillation in the presence of high rate dual chamber pacing.