44 Stratos LV/LV-T Technical Manual

The freedom from Stratos LV system-related and procedure- related complications was 88.76% with a one sided lower 95% confidence bound of 81.69%. Therefore, the null hypothesis was rejected, and it was concluded that the complication-free rate at 6 months is equivalent to 85% within 10% (p = 0.0014).

Observed Adverse Events

Adverse events are classified as either observations or complications. Observations are defined as clinical events that do not require additional invasive intervention to resolve. Complications are defined as clinical events that require additional invasive intervention to resolve.

Of the 29 adverse events reported, there were 18 observations and 11 complications in a total of 89 patients. Table 10 and Table 11 provide a summary by category of each type of adverse event (complications and observations).

Table 10: Summary of Complications at 6 months

 

 

 

Number

% of

 

Number of

 

Complications

 

Category

 

of

 

 

per patient-

 

 

Patients

 

Complications

 

 

 

 

Patients

 

 

year

 

 

 

 

 

 

 

 

Corox OTW/Steroid Lead-Related

 

 

 

Loss of

2

2.2%

 

2

 

0.03

 

 

capture

 

 

 

 

 

 

 

 

 

 

 

 

Phrenic nerve

1

1.1%

 

1

 

0.02

 

 

stimulation

 

 

 

 

 

 

 

 

 

 

 

 

Total

3

3.3%

 

3

 

0.05

 

 

 

 

Atrial Lead Related

 

 

 

Loss of

1

1.1%

 

1

 

0.02

 

 

capture

 

 

 

 

 

 

 

 

 

 

 

 

Total

1

1.1%

 

1

 

0.02

 

 

 

 

RV Lead Related

 

 

 

Loss of

3

3.3%

 

3

 

0.05

 

 

capture

 

 

 

 

 

 

 

 

 

 

 

 

Elevated

 

 

 

 

 

 

 

 

Pacing

2

2.2%

 

2

 

0.03

 

 

thresholds

 

 

 

 

 

 

 

 

Total

5

5.6%

 

5

 

0.08