User Manual Part 4

CLINICAL STUDY - DECREASE HF

C-15

The null hypothesis was to be rejected if the lower one-sided 95% conﬁdence

bound for system related complication rate through six m onths post-implant

were greater than 70%. The system related complication free rate at six months

was 83.2% with a lower 95% conﬁdence bound of 79.7%.

Months from Implant

0 1 2 3 4 5 6

100

N 358 287 285 280 272 268 265

Acceptance Boundary

Percent Free from System Comp

All patients implanted or attempted; N=358.

Event-Free Rate

Lower One-Sided 95% Confidence Bound

Figure C-8. Time to System Related Complication

The Holter Substudy

Ancillary Endpoints

Sixty-nine patients at nine centers were included in the Holter Substudy. Data

were collected at the three-month visit at centers participating in the Holter

Substudy. Holter recordings were analyzed by a Holter core laboratory.

Continuous Appropriate Pacing During Activities of Daily Living––The

safety of CRT therapy provided by the investigational system was assessed by

the percent of time a patient is appropriately paced over a 24-hour period, as

recorded with a Holter monitor at the three-month visit. The appropriateness

of CRT delivery is deﬁned by whether the device delivers CRT in accordance

with the physician’s programming. The objective of this endpoint was to

demonstrate that patients receive continuous appropriate pacing from the

device d uring activities of daily living.

It is expected that patients will receive pacing approximately 95% of the time on

average. The null hypothesis was to be rejected if the lower one-sided 95%

conﬁdence bound of the mean time paced were greater than 90%. Due to the

non-normality of the data, a non-parametric test of the median was performed,

which compared the m edian to 90% inst ead of comparing the lowe r 95%

conﬁdence bound of the mean to 90%.

- DRAFT -