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NCT01370564 · ClinicalTrials.gov registry record · Phase 2
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
A Phase 2 study of Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 3
- Study locations
NCT01370564: Completed Phase 2 study of Heart Failure, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01370564 is a Phase 2 study of Heart Failure that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 21 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01370564, a Phase 2 study of Heart Failure, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Diuretics
Study Locations (3)
Ohio
- Ohio State University - Columbus
Oklahoma
- Oklahoma Cardiovascular Research - Oklahoma City
Virginia
- Sentara Cardiovascular - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01370564
The ClinicalTrials.gov registry entry for NCT01370564 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower). The listed sponsor is Medtronic Cardiac Rhythm and Heart Failure, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Diuretics is the first listed.
NCT01370564 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Oklahoma, Virginia.
Frequently Asked Questions
What is clinical trial NCT01370564 about?
NCT01370564 is a clinical study titled "Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures". 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, an...
What is the current status of trial NCT01370564?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2011-06. Estimated completion is 2012-01.
What conditions does trial NCT01370564 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT01370564?
The interventions under investigation include: Diuretics (DRUG).
Who is sponsoring clinical trial NCT01370564?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01370564 being conducted?
This trial has 3 study locations across Ohio, Oklahoma, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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