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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Treatments: Diuretics

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)