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The purpose of the Extension Phase of the COMPASS-HF study is to continue to observe the safety of the Chronicle® Implantable Hemodynamic Monitor (IHM) system and provide study doctors continued access to the heart pressure information recorded by the Chronicle IHM which may be used to help manage heart failure. The Extension Phase of the COMPASS-HF study is limited to people who have already received the investigational system and are currently enrolled in a Chronicle IHM study.
For the purpose of the Extension Phase, the Chronicle IHM system is for continued use in patients with moderate to severe heart failure and is 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
In all three studies, patients were implanted with a Chronicle IHM 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 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.
Chronicle Implantable Hemodynamic Monitor (IHM) System
Enrolling by invitation
Medtronic Cardiac Rhythm Disease Management
Published on BioPortfolio: 2014-08-27T03:18:48-0400
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