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NCT00643279 · ClinicalTrials.gov registry record · NA

Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

Completed
Registry status
NA
Development phase
277
Enrollment target

NCT00643279: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

NCT00643279 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 277 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00643279, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.

COMPLETED
Registry status
NA
Development phase
277 participants
Enrollment target

Study Summary

COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.

Primary Outcome

A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system. Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.

Interventions

  • OTHER Standard of Care
  • DEVICE Chronicle Implantable Hemodynamic Monitor

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2003-03
Est. Completion 2013-04
Phase NA

What the finished NCT00643279 record still lists

NCT00643279 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.

NCT00643279 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00643279 about?

NCT00643279 is a clinical study titled "Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)". COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel hea...

What is the current status of trial NCT00643279?

This trial is currently completed. It is a NA study. The enrollment target is 277 participants. The study started on 2003-03. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00643279?

The interventions under investigation include: Standard of Care (OTHER), Chronicle Implantable Hemodynamic Monitor (DEVICE).

Who is sponsoring clinical trial NCT00643279?

This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00643279's enrollment target sits among peer trials

277 383rd of 2000 higher than 1,618 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00643279, the US trial registry maintained by the National Library of Medicine. NCT00643279 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.