User Manual

Lumax Technical Manual 29
At the enrollment screening, the physician evaluated the patient
to verify that all inclusion/exclusion criteria were met in
accordance to the protocol and the patient signed the informed
consent. After successful enrollment, all patients were implanted
with the Kronos LV-T CRT-D. Evaluations at the One- and Three-
month follow-ups included resting ECG, NYHA classification,
medications, and activation of Home Monitoring.
1.6.1.2 Summary of Clinical Results
The study involved 45 patients (37
males, 82.2%, and 8 females,
17.8%), with a mean age of 64 years (range: 36-79), a left
ventricular ejection fraction of 26 % (range: 15-43), NYHA Class
III (NHYA Class 1 (2.3%), Class II (11.4%), Class III (79.5%),
Class IV (6.8%)) and QRS duration of 154 ms (range: 84-208).
The mean implant duration was 4.5 months with a cumulative
implant duration of 202 months. The patient follow-up compliance
rate was 95.9% out of 221 required follow-ups.
Primary Endpoint
The safety of the Kronos LV-T was evaluated based on
complications (adverse events that require additional invasive
intervention to resolve) related to the implanted CRT system
which includes the Kronos LV-T, the right atrial lead, the right
ventricular ICD lead, and the left ventricular lead. 5 complications
were seen in 3 patients with cumulative implant duration of 202
months (16.8 patient-years). 6.7% of the patients had a reported
complication. The rate of complications per patient-year is 0.30.
The freedom from Kronos LV-T system-related complications is
93.3% with a two sided lower 95% confidence bound of 83.8%.
The null hypothesis is rejected, and it is concluded that the
complication-free rate is equivalent to 85% within 10%.