At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 247 enrolled
Drug / intervention
46 hrs Holter ECG recordingother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Reveal® XT Performance Trial
In Brief
A Phase 4 clinical trial evaluating 46 hrs Holter ECG recording for Atrial Fibrillation and Risk of Cardiac Arrhythmias. Completed, enrolled 247 participants across 24 sites in 8 countries.
Detailed Summary
The purpose of this study is to quantify the accuracy of the atrial fibrillation diagnostics of the Reveal® XT in a clinical setting and to verify overall system performance, R-wave sensing performance, to obtain user feedback, from both patient and physician, and collect data on device safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Risk of Cardiac Arrhythmias
CountriesAustria, Belgium, Canada, Czechia, Germany, Netherlands, Russia, Slovakia
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedMay 2008
Primary CompletionAug 2008
TodayJul 2026
First PostedMay 20, 2008
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.1 years ago
Interventions
46 hrs Holter ECG recordingother
Maximum of 2 46 hrs external Holter ECG recordings are required.