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Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

NCT00510198 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-04-10

Study results available
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Summary

The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that records information about the heart that doctors can use to help treat their heart disease) combined with standard treatment methods (Access Group) to patients whose heart failure is managed by standard treatment methods only (Control Group). This comparison will show if the additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are first admitted to hospital for heart failure or delays the time to death.

Conditions

  • Congestive Heart Failure

Interventions

DEVICE

Cardiac Compass with OptiVol Fluid Status Monitoring

Review of Cardiac Compass with OptiVol Fluid Status Monitoring

DEVICE

Standard of Care alone (clinical assessment)

Clinical assessment utilizing standard of care, alone.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • PRECEDE-HF Study Team · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00510198 on ClinicalTrials.gov