Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device

Exclusion Criteria

• •Any contraindication for standard cardiac pacing
• •Any contraindication for ICD therapy
• •Abdominal implantation side
• •Hypertrophic or obstructive cardiomyopathy
• •Acute myocarditis
• •Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
• •Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
• •Correctable valvular disease that is the primary cause of heart failure
• •Mechanical tricuspid valve
• •Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week
• •Heart transplant recipient
• •Renal insufficiency requiring dialysis
• •Already included in another clinical study
• •Life expectancy less than 12 months
• •Inability to understand the purpose of the study or refusal to cooperate
• •Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization
• •Unavailability for scheduled follow-up at the implanting center
• •Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
• •Under guardianship
• •Age of less than 18 years
• •Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)