User Manual

32 Lumax Technical Manual
 Ability to complete all required testing including the six-
minute walk test and cardiopulmonary exercise testing
 Available for follow-up visits on a regular basis at the
investigational site
 Age greater than or equal to 18 years
Exclusion Criteria
To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following:
 Previously implanted CRT device
 ACC/AHA/NASPE indication for bradycardia pacing
(sinus node dysfunction)
 Six-minute walk test distance greater than 450 meters
 Chronic atrial tachyarrhythmias refractory to
cardioversion shock therapy
 Receiving intermittent, unstable intravenous inotropic
drug therapy (patients on stable doses of positive
inotropic outpatient therapy for at least One-Month are
permitted)
 Enrolled in another cardiovascular or pharmacological
clinical investigation
 Expected to receive a heart transplant within 6 months
 Life expectancy less than 6 months
 Presence of another life-threatening, underlying illness
separate from their cardiac disorder
 Acute myocardial infarction, unstable angina or cardiac
revascularization within the last 30 days prior to
enrollment
 Conditions that prohibit placement of any of the lead
systems
1.6.2.3 Summary of Clinical Results
A total of 200 patients were enrolled
in the OPTION CRT/ATx
clinical study at 25 sites:
There were 133 study patients and 67 active control patients in
this prospective, multi-center, randomized clinical study. For the
study group, there were 129 successful implants (91.4%) of the
Tupos LV/ATx CRT-D system. For the active control group, there
were 64 successful implants (92.2%) of the legally marketed
CRT-D systems.