Impulse Dynamics AIM HIGHer OPTIMIZER, Руководство для пациента

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1
1.0 INTRODUCTION
You
are participating in an investigation called the AIM HIGH
er
Clinical
Trial
and have received the implantable OPTIMIZER Smart Mini System.
The AIM HIGH
er
Clinical Trial is a
randomized study to
evaluate the
effectiveness of the Cardiac Contractility Modulation (CCM) therapy in
symptomatic heart failure patients
with a
Left Ventricular Ejection Fraction
(LVEF) of ≥ 40% and ≤ 60%
.
This is a blinded study and
you
have been
rando
mly
placed in
to
one of two
patient groups for the first 18 months of
the study
.
You have 67% chance of being placed in the CCM Therapy ON
group and a 33% chance of being placed in the CCM Therapy OFF group.
Neither you nor
your doctor will know
in
which gr
oup you
have been
placed
.
The purpose of this manual is to
provide
you
with information about the
OPTIMIZER Smart Mini system,
what to expect after
your implant
procedure
,
introduce you to
the components of the system
, and provide
you with
instructions on
how to use
the Vesta Charger.
2.0 THE OPTIMIZER SMART MINI SYSTEM
The OPTIMIZER Smart Mini s
ystem is comprised of the following
components:
•
OPTIMIZER Smart Mini
Implantable Pulse Generator (IPG)
•
Vesta Charger
2.1 OPTIMIZER Smart Mini Implantable Pulse
Generator
The OPTIMIZER Smart Mini
Implantable Pulse Generator (IPG)
is
a medical device used
for the treatment of NYHA Class III heart
failure.
It is typically implanted under the skin in
the upper left or
right chest.
Connected to the
OPTIMIZER Smart Mini
IPG
are t
w
o (or
optionally three) cardiac leads that your doctor will insert through
a large vein
and into the heart during the implantation process
.
These leads have electrodes that allow the
OPTIMIZER Smart
Mini
IPG to monitor the electrical activity of your heart and deliver
special
Cardiac Contractility Modulation (CCM)
therapy pulses to
the heart at a specific time
during
each heart
beat
.