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

Inclusion Criteria:

• Patient eligible for implantation of a CRT-D device according to current availableguidelines for cardiac resynchronization therapy

• Severe HF (NYHA Class III or IV) at the time of enrollment

• At least one HF-related event (as defined for primary objective) within the last 6months before enrolment

• Subject continues to have heart failure symptoms despite receiving optimal medicaltherapy consistent with current practice guidelines for the pharmacological managementof heart failure

• Scheduled for implant of a PARADYM 8770

• Signed and dated informed consent

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 lastmonth

• Recent (within the last month) or planned cardiac revascularization or coronaryangioplasty

• Correctable valvular disease that is the primary cause of heart failure

• Mechanical tricuspid valve

• Receiving continuous intra-venous infusion of positive inotropic therapy orintermittent 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 informedconsent, 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 priorto enrollment)