Stratos LV/LV-T Technical Manual 51
• 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
Clinical 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
