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20 Stratos LV/LV-T Technical Manual
Clinical Exclusion Criteria
To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following:
• Meet one or more of the contraindications
• Have a life expectancy of less than six months
• Expected to receive heart transplantation within six
months
• Enrolled in another cardiovascular or pharmacological
clinical investigation
• Patients with an ICD, or being considered for an ICD
• Patients with previously implanted biventricular pacing
systems
• Patients with previously implanted single or dual
chamber pacing system with > 50% documented
ventricular pacing
• Patients with previous AV node ablation
• Six-minute walk test distance greater than 450 meters
• Any condition preventing the patient from being able to
perform required testing
• Presence of another life-threatening, underlying illness
separate from their cardiac disorder
• Conditions that prohibit placement of any of the lead
systems
Follow-Up Schedule
At the enrollment screening, the physician evaluated the patient
to verify that all inclusion/exclusion criteria have been met in
accordance to the protocol and the patient has signed the
informed consent. After successful enrollment, all patients were
implanted with either a Stratos LV CRT-P or Protos DR/CLS
device. Evaluations at the Four Week, Three and Six Month
follow-ups included NYHA classification, medications, and
percentage of ventricular pacing.