User Manual

Lumax Technical Manual 51
Select permanent “Initially Paced Chamber” and “V-V delay after
Vp” to reflect the maximum VTI measurement for final
programming.
Inclusion Criteria
To support the objectives of this investigation, the inclusion
criteria at the time of patient enrollment for this investigational
study included the following requirements:
 Meet the indications for therapy.
 Successfully implanted with a BIOTRONIK Lumax HF-T
CRT-D system and have received SIM for a minimum of
30 days prior to enrollment.
 Treated with stable and optimal CHF medications.
 Age ≥ 18 years.
 Able to understand the nature of the study and give
informed consent.
 Able to complete all testing required by the clinical
protocol, including the 6-minute walk test and QOL
questionnaire.
 Available for follow-up visits on a regular basis at the
investigational site.
Exclusion Criteria
To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following
requirements:
 Meet one or more of the contraindications.
 Have a life expectancy of less than 6 months.
 Expected to receive heart transplantation within 6
months.
 Have had more than 1 CHF-related hospitalization within
past 30 days.
 Currently receiving IV inotropic medications.
 Chronic atrial fibrillation.
 Enrolled in another cardiovascular or pharmacological
clinical investigation, except for FDA required post-market
registries.
 Any condition preventing the patient from being able to
perform required testing.