User Manual

6. CLINICAL STUDIES
6. CLINICAL STUDIES
Clinical data presented in this section are from the Defender study. INTENSIA VR 124 is
similar in design and function to the Defender devices. The data provided are applicable to
INTENSIA VR 124.
6.1. DEFENDER STUDY
Objectives:
The primary objectives of this study were to demonstrate a complication free rate (CFR)
comparable to that of historical controls, to demonstrate, using a chronotropic assessment
exercise protocol (CAEP), a rate response proportional to and appropriate for the level of
exercise, and to evaluate and report the incidence of adverse events.
Materials:
Each patient received one Defender IV DR 612 defibrillator, an atrial pacing and sensing
lead, and a Medtronic, Angeion, or Biotronik defibrillation lead in the U.S. or any
commercially available defibrillator lead outside the U.S.
Methods:
Investigators selected patients who survived at least one episode of cardiac arrest
(manifested by loss of consciousness) presumably due to a ventricular tachyarrhythmia or
exhibited recurrent, poorly tolerated, sustained ventricular tachycardia (VT). The protocol
required evaluation of performance and adverse events at pre-discharge, one month, three
months, six months, and (in the U.S.) every three months thereafter. At the one-month visit,
eligible patients performed a chronotropic assessment exercise protocol (CAEP) maximal
exercise test.
Study Population.
The table below summarizes inclusions.
Region Date of first
implant
Date of last
implant
Data cut-off
date
Number of
centers
Number of
patients
US 14-Dec-99 08-Mar-00 14-Mar-00 6 22
Europe 04-May-99 26-Jul-99 14-Apr-00 11 38
All 04-May-99 08-Mar-00 14-Apr-00 (Eur),
14-Mar-00 (US)
17 60
6.1.1 . Complication-free rate
Only European patients followed for at least 3 months:
Symbol Parameter Defender IV DR 612
N Overall number of patients 37
Pe*N Number of successes 35
SORIN – INTENSIA VR 124 – U153A
15