Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study
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|ClinicalTrials.gov Identifier: NCT00991120|
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : November 30, 2017
|Condition or disease||Intervention/treatment|
|Heart Failure||Device: Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)|
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.
|Study Type :||Observational|
|Actual Enrollment :||165 participants|
|Official Title:||Extension Phase of the Chronicle® Offers Management to Patients With Advanced Signs & Symptoms of Heart Failure Study|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
- Device: Chronicle Implantable Hemodynamic Monitor (IHM) System, Chronicle Implantable Cardioverter Defibrillator (ICD)
Surgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac leadOther Name: Chronicle IHM, Chronicle ICD
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991120
Show 19 Study Locations
|Study Chair:||COMPASS-HF Extension Team||Medtronic|