User's Manual

18 Cardiac Airbag Technical Manual
1.6.2 Methods
The multicenter clinical investigation was designed to validate
the safety and effectiveness of the ICD system to detect and
treat monomorphic ventricular tachycardia (MVT), polymorphic
ventricular tachycardia (PVT), ventricular fibrillation (VF), and
bradycardia. The specific predefined objectives of the
investigation included the determination of ventricular
tachyarrhythmia conversion rate, sudden cardiac death (SCD)
survival rate, morbidity rate, and the appropriate sensing and
pacing rate.
The primary endpoint of the study was to evaluate the ventricular
tachyarrhythmia conversion rate. Patients underwent standard
ICD implantation and then were evaluated at predischarge and
regular follow-ups every three months. Induction and conversion
of the patient’s tachyarrhythmias was required at the implant
procedure and predischarge follow-up.
1.6.3 Results
The mean implant duration was 8.3 ± 0.4 months with
cumulative implant duration of 1286 months. There were 39
patients followed for over twelve months and 108 patients
followed for over six months. The patient follow-up compliance
rate was 99.6% out of 473 follow-up procedures.
Table
2 provides a summary of the results of the study group for
the predefined endpoints.