Fast VT Episodes Are Terminated by ATP One Shot
Fast VT Episodes Are Terminated by ATP One Shot
Many arrhythmias detected in the ventricular fibrillation (VF)-zone picture monomorphic
 ventricular tachycardia (VT) and, hence, could be terminated by antitachycardia pacing (ATP)
 treatment. Advantages of successful ATP are the painlessness termination and the shortened
 duration of arrhythmia. The ATP One Shot algorithm is integrated in the latest family of
 implantable cardioverter defibrillators (ICDs) from BIOTRONIK (Lumax). It allows a single
 delivery of ATP before charging capacitors to terminate lethal arrhythmia by painful shock.

 The present study evaluates the efficacy of the ATP One Shot algorithm for the termination of
 fast VT episodes. 200 patients with secondary prophylactic ICD indication will be followed
 for 18 months. Spontaneous episodes detected in the VF-zone of the ICD will be evaluated with
 regard to cycle length, episode duration and course of device therapy.
ICDs provide different detection zones for the therapy of VT and VF. An established form of
 therapy in the VT-zone is antitachycardia pacing (ATP). It is an effective, safe and painless
 method to terminate episodes of slow VT with a cycle length > 300 ms. Episodes detected in
 the VF zone will result in the delivery of a high-energy shock to terminate life-threatening
 VF. Many arrhythmia detected in the VF-zone picture monomorphic VT and could be easily
 terminated by ATP. Advantages of a successful termination by ATP therapy would be the
 painlessness and the shortened duration of the episode, as there would be no need to load
 shock capacitors. Fast VT are often hemodynamically poorly tolerated by the patient and
 should be terminated within very short time. The ATP One Shot algorithm is integrated in the
 latest family of ICDs from BIOTRONIK (Lumax) to allow a single delivery of ATP before
 charging capacitors.

 The main objective of the study is the assessment of the efficacy of the ATP One Shot
 algorithm for the termination of fast VT episodes. To this end, spontaneous episodes detected
 in the VF-zone of the ICD are evaluated with regard to cycle length, episode duration and
 course of device therapy. In the context of the study, a confirmatory (hypothesis-testing)
 primary problem is investigated. The goal is to measure the time to first adequate shock
 therapy for episodes detected in the VF-zone of the device and to analyze the hazard ratio of
 the standard ICD setting compared to a therapy with the ATP One Shot algorithm.

 The clinical project is conducted as randomized prospective multicenter study. The
 chronological order and the scope of the follow-ups meet the medical standard according to
 the international guidelines. A center-based, stratified block randomization will be
 performed. In approximately 50% of the patients the ATP One Shot algorithm will be activated,
 while the other 50% will be randomized into the control group.

 A total of about 20 European investigational sites will participate in the study. Each center
 should enroll about 10 patients who will be followed for 18 months.
Inclusion Criteria:

 -  ICD indication for reason of survived cardiac arrest, ventricular tachycardia or
 syncope

 Exclusion Criteria:

 -  ICD indication for reason of non-sustained VT post MI, positive family history for SCD
 (Brugada-, long/short QT-Syndrome), hypertrophic cardiomyopathy, primary prophylactic
 indication (e.g. SCD-HeFT, Madit II)

 -  Patients not capable of participating in the follow-ups

 -  Minors and pregnant women

 -  Patients who are already enrolled in another study