Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures

Subjects will be asked to transmit to the CareLink Network daily. Data specific to this study
(subject's daily estimated Pulmonary Arterial Diastolic (ePAD) pressure values) will be
extracted from the CareLink database and transferred to the IPC clinician website.

As each subject is enrolled, clinicians at each participating site will determine the
appropriate target pressure range for each subject based on a review of the subject's
pressure data. Each day after enrollment, the subject's current pressure data will be
compared to a target pressure range that the clinician sets for that subject.

The patient instruction set (PtIS) is limited to a daily diuretic prescription and associated
supplements, per physician discretion. The PtIS should not include adjustments of non-heart
failure medications and should not include heart failure medications that are not indicated
for day-to-day adjustments (e.g. ACE-Inhibitors, Angiotensin Receptor Blockers (ARBs), and
Beta-Blockers). The PtIS will be sent from the IPC clinician website to the subject through a
Patient Home Monitor.

Inclusion Criteria:

- Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle
ICD device (Model 7286)

- Patients who have been prescribed daily diuretic therapy for the management of heart
failure

- Patients currently participating in the COMPASS-HF Extension Phase Study (IDE
#G020304)

- Patients willing and able to give informed consent

Exclusion Criteria:

- Patients with non-physiologic Right Ventricular (RV) pressure values

- Patients who have diuretic resistance

- Patients who have an estimated Glomerular Filtration Rate(eGFR) <30 ml/min (recorded
within the last six months)

- Patients who have a Chronicle IHM device (Model 9520) that was implanted as part of
the Pulmonary Arterial Hypertension (PAH) Pilot Study (IDE #G020303)

- Patients who do not have the ability to actively participate in the management of
their own heart failure care (determine by physician discretion)(e.g. patient does not
have ability to operate study equipment, patient does not have a history of compliance
to sending CareLink transmissions)

- Patients who have a reasonable probability of needing a device replacement during the
study (approximately two months)

- Patients enrolled or planning to participate in a concurrent drug and/or device study
during the course of this clinical trial

- Patient who are pregnant (all females of child-bearing potential must have a negative
pregnancy test within 1 week of enrollment)