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NCT01486316 · ClinicalTrials.gov registry record · NA
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT01486316: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01486316 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01486316, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.
Primary Outcome
Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such
Interventions
- DEVICE Reveal XT® Insertable Cardiac Monitor
- OTHER Heart Failure Risk Status Diagnostic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-02 |
| Phase | NA |
What the finished NCT01486316 record still lists
NCT01486316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Reveal XT® Insertable Cardiac Monitor is the first listed.
NCT01486316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01486316 about?
NCT01486316 is a clinical study titled "Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure". The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the...
What is the current status of trial NCT01486316?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2011-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01486316?
The interventions under investigation include: Reveal XT® Insertable Cardiac Monitor (DEVICE), Heart Failure Risk Status Diagnostic (OTHER).
Who is sponsoring clinical trial NCT01486316?
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 NCT01486316's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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