Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study

This is a multi-center feasibility study.

Inclusion Criteria:

- Age > 18 and ≤ 85.

- Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D.
Alternatively, the patient may already have in place an existing Promote CRT-D or
other SJM CRT device with similar functions, or have a CRT-D device that requires a
generator change. In addition, the patient may be already enrolled in HOMEOSTASIS I or
II and completed the 12-month follow-up.

- Central venous vascular access.

- Have a legally marketed right atrial bipolar pacing lead, a right ventricular bipolar
defibrillation lead, and a left ventricular bipolar pacing lead.

- Demonstrate capability of Valsalva maneuver with airway pressure > 40 mm Hg for ≥10
seconds.

- The subject and the treating physician agree that the subject is geographically stable
and willing to comply with all required post-procedure follow-up, and that the patient
is capable of correct device use as outlined in the protocol.

- The subject has been informed of the nature of the study and agrees to its provisions
and has provided written informed consent as approved by the Institutional Review
Board or Ethics Committee of the respective clinical site

Exclusion Criteria:

- Intractable HF with resting symptoms despite maximal medical therapy (AHA/ACC Stage D)
or active listing for cardiac transplantation (<6 months survival expected).

- Resting systolic blood pressure < 90 or > 180 mm Hg.

- Acute Myocardial Infarction (MI), unstable ischemic syndrome within the last 6 weeks.

- Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned
within ± 6 weeks.

- Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy,
amyloidosis or other infiltrative heart disease, constrictive, restrictive disease,
tamponade, or moderate or large pericardial effusion.

- Subject has a history of deep venous thrombosis or pulmonary embolism within the last
6 months.

- Surgical correction of congenital heart disease involving atrial septum that will
prevent safe implantation of the SJM HeartPOD ISL.

- Cerebral Vascular Accident (CVA) or Transient Ischemic Attacks (TIA's) within the last
6 months. History of uncorrected cerebral vascular disease.

- Atrial or ventricular thrombus, tumor or systemic thromboembolism.

- Atrial septal defect or clinically significant patent foramen ovale.

- Life expectancy less than one year from malignancy, primary pulmonary hypertension,
renal, hepatic, or neurological condition, etc.

- Gastrointestinal bleeding during the last 6 months.

- Coagulopathy or uninterruptible anticoagulation therapy or unable to take antiplatelet
medications.

- Creatinine > 2.4 gm/dl (212 µmol/L) at enrollment.

- Active systemic infection.

- The subject is currently participating in an investigational drug or another device
study that has not completed the primary endpoint or that clinically interferes with
the current study endpoints.

- Have a contraindication for an emergency thoracotomy

- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or
short term contact with heparin.

- Positive pregnancy test at enrollment or planning a pregnancy in the next 12 months.

- Patient is pacemaker dependent, where cessation of pacemaker function consistently
results in syncope or ventricular asystole.

- Incompatible previously implanted intracardiac devices.