User Manual Part 4

E-4

CLINICAL STUDY - CONTAK RENEWAL

Inclusion/Exclusion Criteria

Patients who were enrolled in the study were required to meet the following

inclusion criteria:

• Availability for 24 ho urs follow-up at an approved study center

• Willingness and ability t o participate in all testing associated with this s tud y

• Age 18 or above, or of legal age to give informed consent as speciﬁed

by national law

• Implanted with the C ONTAK RENEWAL system for at least 1 month

• Stable when programmed according to labeled recommendations for

continuous BV pacing

• Sinus rhythm at follow-up

• Active a tria l lead imp lanted

Patients were excluded from the investigation if they met any of the following

criteria:

• Life expectancy of less than six months due to other medical conditions

• Concurrent participation in any other clinical study, including drug study

•Inatrialﬁbrillation at follow-up

• Inability or re fusal to sign the Patient Informed Consent

• Inability or refusal to co mply with the follo w-up schedule

• Known pregnancy

Demographic D ata

The patient characteristics at s tudy entry are summarized in Table E-2 on page

E-4.

Table E-2 . Pre-implant characteristics of study patients

Characteristics

Patient Data

N patients 46

Gender Male: 40 (87%), Female: 6 (13%)

Age (years)

60.9 ± 9.0

NYHA at implant [N (%)]

0(0%)

5(10.9%)

III

34 (73.9 %)

- DRAFT -