Phase 2
N=21
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01370564 ↗Enrolled (actual)
21
Serious AEs
9.5%
Results posted
Jul 2018
Primary outcome: Primary: Characterize the Technical Feasibility of the Network Based IPC System — 72 percentage of days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Diuretics (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Characterize the Technical Feasibility of the Network Based IPC System |
72 | — |
| SECONDARY Characterize the Rate of IPC Setup System Changes |
0.2 | — |
| SECONDARY Quantify Subject Compliance to Daily PtIS |
0.994 | — |
| SECONDARY Estimate Changes in Clinical Markers of Heart Failure and Kidney Function |
1 | — |
| SECONDARY Summarize Adverse Events |
2; 19; 0; 21; 0; 21 | — |
| SECONDARY Estimate Changes in Clinical Markers of Heart Failure and Kidney Function |
1 | — |
| SECONDARY Estimate Changes in Clinical Markers of Heart Failure and Kidney Function |
1 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01370564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.