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

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic
feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac
Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.

Inclusion Criteria:

- Patient eligible for implantation of a CRT-D device according to current available
guidelines 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 6
months before enrolment

- Subject continues to have heart failure symptoms despite receiving optimal medical
therapy consistent with current practice guidelines for the pharmacological management
of 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 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)