sorin Intensia DR 154, Руководство по имплантации

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6. CLINICAL STUDIES
6. CLINICAL STUDIES
Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD)
clinical studies. INTENSIA DR 154 is similar in design and function to the Defender
devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony
pacemaker. The data provided are applicable to INTENSIA DR 154.
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
16 SORIN – INTENSIA DR 154 – U152A