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

Completed

Conditions studied: Heart Failure

In brief

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 Chronicle ICD system and provide study doctors continued access to the heart pressure information recorded by the Chronicle devices 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 or ICD study.

Key facts

Study ID

NCT00991120

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

165

Starts

2009-10-01

Expected to finish

2013-04-01

Last updated by the study team

2017-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Springfield, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Davenport, Iowa, United States
• Study site — Boston, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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