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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.

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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.

Primary Outcome

The proportion of study days a PtIS is based on the subjects' daily pressure state

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

FieldValue
Enrollment Target 21 participants
Start Date 2011-06
Est. Completion 2012-01
Phase Phase 2

What the finished NCT01370564 record still lists

NCT01370564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (99% lower).

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 a single indexed study location in 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.

Similar trials for Heart Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01370564's enrollment target sits among peer trials

21 344th of 397 higher than 49 of 397 other Heart Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01370564, the US trial registry maintained by the National Library of Medicine. NCT01370564 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.