BIOTRONIK Lumax DR ICD Series, Техническое руководство, Страница: 39 / 176

Lumax Technical Manual 31
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For patients with an existing ICD/CRT-D, optimal and
stable CHF drug regimen including ACE-inhibitors and
beta-blockers unless contraindicated (stable is defined as
changes in dosages less than 50% during the last 30
days)
•
Indicated for ICD therapy
•
History or significant risk of atrial tachyarrhythmias
•
Willing to receive possibly uncomfortable atrial shock
therapy for the treatment of atrial tachyarrhythmias
•
Able to understand the nature of the study and give
informed consent
•
Ability to tolerate the surgical procedure required for
implantation
•
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