40 Stratos LV/LV-T Technical Manual
Clinical Inclusion Criteria
To support the objectives of this investigation, patients were
required to meet the following inclusion criteria prior to
enrollment:
• Meet the indications for bi-ventricular pacing
• Age ≥ 18 years
• Receiving optimal drug therapy for Congestive Heart
Failure treatment
• Give informed consent
Clinical Exclusion Criteria
To support the objectives of this investigation, the exclusion
criteria at the time of patient enrollment included the following
requirements:
• Myocardial infarction or unstable angina pectoris
• Acute myocarditis
• Life expectancy ≤ 6 months
• Planned cardiac surgical procedures or interventional
measures within the next 6 months
• Pregnancy
Follow-Up Schedule
All patients were implanted with the Corox OTW/Steroid LV lead
system and a CRT-P or CRT-D pulse generator capable of
providing bi-ventricular pacing for the treatment of CHF. The
specific study procedures were performed at:
• Pre-operative Visit
• Implantation
• Pre-discharge follow-up
• One-month follow-up
• Three-month follow-up
• Six-month follow-up
• Twelve-month follow-up
