Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study

For the purpose of the Extension Phase, the Chronicle IHM and ICD systems are for continued
use in patients with moderate to severe heart failure and are intended to monitor hemodynamic
information, including right ventricular and pulmonary artery pressures, heart rate and
activity. The COMPASS-HF Extension Phase includes the following Chronicle IHM studies:

- The Chronicle IHM Phase I/II study, which was a 148 patient technology assessment study
that began enrolling patients in 1998 and completed the endpoint driven follow up period
of 3 months for safety and 12 months for efficacy in 2002

- The Chronicle Offers Management to Patients with Advanced Signs & Symptoms of Heart
Failure (COMPASS-HF) study, which was a 274 patient randomized study that began
enrolling patients in 2003 and completed the endpoint driven follow up period of 6
months in 2005

- The Pulmonary Arterial Hypertension Pilot (PAH Pilot) study, which was a 24 patient
pilot study that began enrolling patients in 2003 and completed the endpoint driven
follow up period of 12 weeks in 2006

- The Reducing Decompensation Events Utilizing intraCardiac Pressures in Patients with
Chronic HF (REDUCEhf) study, which was a 400 patient randomized study that began
enrolling patients in 2006 and completed endpoint driven follow up period of 12 months
in 2010.

In all four studies, patients were implanted with a Chronicle IHM or ICD system and upon
completion of the endpoint driven follow up period, entered long term follow up and have
continued to be seen every six months for study visits.

As the Chronicle IHM or ICD system has not received U.S. Food and Drug Administration
approval, the COMPASS-HF Extension Phase is being initiated as a means to allow continued
access of Chronicle IHM data to study investigators in one concurrently enrolled study and
follow up schedule. No additional study objectives or new enrollments will be captured in the
COMPASS-HF Extension Phase.

Inclusion Criteria:

- Patient provides written informed consent for the Extension Phase

- Patient has an implanted Chronicle IHM or ICD device and is actively enrolled in one
of the following studies: COMPASS-HF, Chronicle IHM Phase I/II, REDUCEhf or the PAH
Pilot Study

Exclusion Criteria:

- Patient unwilling to transmit their Chronicle IHM or ICD device data as directed by
their study clinicians or unwilling to participate in protocol scheduled follow up
visits (every six months)