User Manual Part 4

CLINICAL STUDY - C ONTAK CD
D-5
Tab le D-1. A dverse events through randomization perio d (continued)
# Of Events
(# of pts)
%
Complications
(Patients)
Complicatio ns
per 100
Device Months
(Events)
%
Observations
(Patients)
Observations
per 100
Device Months
(Events)
Subtotal
Cardiovascular-
Related Events
358 (200) 7.7 (40) 1.6 (42) 35.6 (184) 12.2 (316)
Tota l
Noncardiovascular-
Related Events
142 (92) 6.2 (32) 1.5 (39) 13.5 (70) 4.0 (103)
Deaths
A total of 109 deaths occurred during the study. These deaths occurred during
the study periods as shown in Table D-2 on page D -5 along with the cause of
death as adjudicated by an independent events committee.
Table D-2 . Deaths that occurre d during CONTAK CD study
Cause of Death
Study Period
a
#ofpt
deaths
Cardiac:
Pump
Failure
Cardiac:
Arrhythmic
Cardiac:
Other
Non-
cardiac
Unknown
After unsuccessful implant
procedure
21 1 0 0 0
Peri-operative (≤ 30 days)
10
5
2021
Randomized therapy phase: No
CRT
b
16 9 0 1 3 3
Randomized therapy phase: CRT
b
11 4 1 2 2 2
Post-randomized therapy phase
c
70 26
5
11620
Total 109 47 9 4 23 26
a. All patients enrolled, N = 581.
b. Day 31 to 120 for Phase I patients, day 31 to 210 for Phase II patients.
c. Day 121 and beyond for Phase I patients, day 211 and beyond for Phase II patients.
STUDY DESIGN
The CONTAK CD Study was a prospective, randomized, controlled,
multi-center, double-blind study conducted at 47 sites in the United States
and enrolled a total of 581 patients. All patients enrolled were intended to be
implanted with a device capable of delivering both CRT and treating ventricular
tachyarrhythmias. Patients were randomized to CRT Off (VVI lower rate 40)
- DRAFT -