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NCT00510198 · ClinicalTrials.gov registry record · NA
Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Terminated
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT00510198: Clinical Trial NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT00510198 is a NA study that was terminated before completion, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00510198, a NA study, was terminated before completion, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- TERMINATED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study 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.
Primary Outcome
A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring ("Access Arm") compared to HF subjects managed with standard clinical assessment alone ("Control Arm")
Interventions
- DEVICE Cardiac Compass with OptiVol Fluid Status Monitoring
- DEVICE Standard of Care alone (clinical assessment)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-04 |
| Phase | NA |
Why NCT00510198 stopped before completion
NCT00510198 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Cardiac Compass with OptiVol Fluid Status Monitoring is the first listed.
NCT00510198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00510198 about?
NCT00510198 is a clinical study titled "Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure". 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 treatmen...
What is the current status of trial NCT00510198?
This trial is currently terminated. It is a NA study. The enrollment target is 120 participants. The study started on 2007-10. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00510198?
The interventions under investigation include: Cardiac Compass with OptiVol Fluid Status Monitoring (DEVICE), Standard of Care alone (clinical assessment) (DEVICE).
Who is sponsoring clinical trial NCT00510198?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00510198's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 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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