User's Manual

US-ENGLISH – 19
6. CLINICAL STUDIES
Clinical data presented in this section are from the Defender and
SafeR clinical studies. PARADYM RF DR 9550 is similar in design
and function to the Defender devices. SafeR operation in
PARADYM RF is similar to that in the Symphony pacemaker. The
data provided are applicable to PARADYM RF DR 9550.
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.