54 Stratos LV/LV-T Technical Manual

Table 13: Patient Demographics at Pre-Enrollment

 

Characteristic

 

 

Study

 

 

Control

 

 

P-

 

 

 

 

N=133

 

 

N=67

 

 

value

 

 

 

 

 

 

 

 

 

 

 

Age at Enrollment (Years)

69.5 ± 0.9

 

69.1 ± 1.2

 

0.781*

 

 

Mean ± SE

 

 

 

 

Range

 

43 to 88

 

38 to 84

 

 

 

 

Gender

93 (69.9%)

 

51 (76.1%)

 

0.407**

 

 

Male

 

 

 

 

Female

40 (30.1%)

 

16 (23.9%)

 

 

 

 

 

Underlying Heart Disease

100 (75.2%)

 

54 (80.6%)

 

0.294***

 

Ischemic Cardiomyopathy

 

 

 

Nonischemic Cardiomyopathy

34 (25.6%)

 

15 (22.4%)

 

 

 

 

 

Type of Bundle Branch Block

91 (68.4%)

 

49 (73.1%)

 

 

 

 

 

Left Bundle Branch Block

 

 

0.877***

 

Right Bundle Branch Block

26 (19.5%)

 

10 (14.9%)

 

 

 

 

 

 

 

 

Other

19 (14.3%)

 

11 (16.4%)

 

 

 

 

 

New York Heart Association

 

 

 

 

 

 

 

 

 

 

Class

121 (91.0%)

 

60 (89.6%)

 

0.800**

 

 

Class III

 

 

 

 

 

 

 

 

 

 

Class IV

12 (9.0%)

 

7 (10.4%)

 

 

 

 

 

Intrinsic QRS Duration (ms)

161.9 ± 2.0

 

156.1 ± 2.3

 

0.073*

 

 

Mean ± SE

 

 

 

 

Range

 

130 to 252

 

130 to 200

 

 

 

 

Left Ventricular Ejection

 

 

 

 

 

 

 

 

 

 

Fraction (%)

22.1 ± 0.6

 

23.3 ± 0.8

 

0.255*

 

 

Mean ± SE

 

 

 

 

 

 

 

 

 

 

Range

 

5 to 35

 

10 to 35

 

 

 

 

Six Minute Walk Distance

 

 

 

 

 

 

 

 

 

 

(meters)

 

 

 

250.5 ±

 

0.775*

 

 

Mean ± SE

254.8 ± 8.9

 

 

 

 

Range

 

11.9

 

 

 

 

 

 

20 to 451

 

 

 

 

 

 

 

 

 

27 to 447

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Quality of Life Questionnaire

 

 

 

 

 

 

 

 

 

 

Score

54.3 ± 2.1

 

52.5 ± 3.1

 

0.638*

 

 

Mean ± SE

 

 

 

 

 

 

 

 

 

 

Range

 

0 to 105

 

0 to 102

 

 

 

*Student's t-test (2-sided) for means, **Fisher's Exact Test (2-sided) for 2 possible answers, ***Chi-Square test (2-sided) for more than 2 possible answers