BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 35 / 176

Lumax Technical Manual 27
1.6 Clinical Studies
The Kronos LV-T Clinical study (HOME-CARE, Section 1.6.1 )
supports the safety of the Lumax CRT-D/ICD device family.
Additionally, because the Tupos LV/ATx and the Lumax CRT-D
devices have identical CRT and ventricular ICD therapy, the
effectiveness results from the OPTION CRT/ATx IDE Clinical
study (Tupos LV/ATx,
Section 1.6.2 ) support the effectiveness of
the Lumax family.
1.6.1 Kronos LV-T Study
The purpose of the HOME-CARE Observational Study is to
demonstrate the safety of the CE-marked Kronos LV-T cardiac
resynchronization defibrillator (CRT-D) in patients with congestive
heart failure (CHF).
1.6.1.1 Methods
The multi-center, non-randomized observational study was
designed to evaluate the safety of the Kronos LV-T through an
analysis of the complication-free rate through three months.
The Home-CARE Observational Study Primary Endpoint was to
evaluate 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
Inclusion Criteria
To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to enrollment:
•
Indication for Cardiac Resynchronization Therapy
•
Sufficient GSM-network coverage in the patient’s area
•
Age greater than or equal to 18 years