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