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.