User Manual

5. CLINICAL STUDIES
ALIZEA SR is limited to single chamber features, but is otherwise the same as ALIZEA DR.
ALIZEA DR and SR offer features which have been evaluated during clinical study of Reply
DR, whose results are presented in the following paragraph:
METHODS
All patients were implanted with a REPLY DR rate-responsive dual-chamber pacemaker.
A variety of marketed atrial and ventricular pacing and sensing leads were used. The
pacemaker was programmed and interrogated via bi-directional telemetry using a
programmer and a CPR3 programming head.
The study’s routine evaluation consisted of pre-implant screening, implant, pre-discharge
evaluation, and scheduled follow-up visit at one month. During hospitalization, a 24-hour
Holter recording was performed and pacemaker memory was read. At one month, pacemaker
memory was read. Investigators also documented adverse events.
PATIENTS STUDIED
A total of 71 patients from 15 centers were implanted with REPLY DR pacemakers. Of these,
38 (54%) were female and 33 (46%) were male. Patient age ranged from 46 to 96 with a
mean age (±SD) of 74 ± 10 years.
Primary indications for implant were: sinus dysfunction (39%), AV block and/or branch block
(38%), sinus dysfunction and AV block and/or branch block (20%) or other (3%).
SAFETY RESULTS
To determine the safety of the REPLY DR system (REPLY DR pacemaker, RA lead, RV lead
and programming system), procedure and system complication-free rate was reported at one
month.
The following table presents the complication-free rate estimate and its bilateral 95%
confidence interval at one month.
Number of pa-
tients included
Number of patients with
complications
Complication free-rate estimate (bilateral
95% confidence interval)
71
1
1
98.57 % (92.29 %, 99.96 %)
The incidence and nature of adverse events are described in "Contraindications and adverse
events" section.
EFFECTIVENESS RESULTS
To determine the effectiveness of system performances, a 24-hour Holter recording was
performed and pacemaker memory was read during hospitalization. A 24-hour Holter
recording or pacemaker memory was defined as a success if it presented both of the following
conditions:
― absence of unexpected ventricular cycle longer than programmed maximal ventricular
pause in SafeR mode or twice of the current escape interval in other modes
5.1.
5.2.
5.3.
5.4.
1. The complication reported is linked to the system (lead dislodgment).
5. CLINICAL STUDIES
ALIZEA – UA10414A 19