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

Completed · Phase 2

Conditions studied: Heart Failure

In brief

This chronic, prospective, non-randomized feasibility study is designed to evaluate the Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers Management to Patients with Advanced Signs \& Symptoms of Heart Failure (COMPASS-HF) Extension Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling pressures from the Chronicle device to provide timely medication adjustments (diuretics) to subjects.

Key facts

Study ID

NCT01370564

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

21

Starts

2011-06-01

Expected to finish

2012-01-01

Last updated by the study team

2018-07-11

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Ohio State University — Columbus, Ohio, United States
• Oklahoma Cardiovascular Research — Oklahoma City, Oklahoma, United States
• Sentara Cardiovascular — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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