User's Manual

6. CLINICAL STUDIES
In a representative reference group
(1)
of patients programmed to DDD, none had less than 1
% ventricular pacing and only 10 % had less than 90 % ventricular pacing regardless of AV
block indication at implant.
The actual reduction of ventricular pacing that SafeR (AAI <> DDD) provides in an individual
will depend on the amount of time that the patient spends in AV block. SafeR (AAI <> DDD)
cannot and should not provide any decrease in ventricular pacing while the patient is in AV
block.
(1)
Pioger G, Jauvert G, Nitzsché R, Pozzan J, Laure H, Zigelman M, Leny G, Vandrell M,
Ritter P, and Cazeau S. Incidence and predictive factors of atrial fibrillation in paced
patients. PACE, 28, Supp 1: S137-141; January 2005. This was a prospective observational
study of 377 patients with a functionally similar device programmed to DDD. The primary
indications for implant were: AV block (49 %), sinus node disease (16 %), brady-tachy
syndrome (5 %), AV block + sinus node disease (19 %), AV block + brady-tachy syndrome
(6 %), and brady-tachy syndrome + sinus node disease (5 %).
Adverse events
Clinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in
45 patients. No serious adverse events were device- or feature-related. There were no
deaths in the study. Table 1 summarizes the safety data for this study.
Table 1: Summary of Symphony safety data during study
Patients Number of events
Number of
patients
% of patients Number of
events
Events per
device year
(a)
Deaths 0 0 0 0
Explants 0 0 0 0
Serious
pacemaker
related events
outside the use of
SafeR (AAI <>
DDD)
0 0 0 0
Non-serious
pacemaker
related events
outside the use of
SafeR (AAI <>
DDD)
0 0 0 0
Serious events
due to the use of
SafeR (AAI <>
DDD)
0 0 0 0
Non-serious
events related
due to the use
SafeR (AAI <>
DDD)
13 28.9 15 3.2
Serious non-
pacemaker
related events
6 13.3 9 1.9
Non-serious non-
pacemaker related
events
8 17.8 8 1.7
20
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