CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 447 enrolled
Drug / intervention
Reveal® XT Insertable Cardiac Monitordevice
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.

Search/NCT00924638
NCT00924638Phase 4Completed

CRYptogenic STroke And underLying AF Trial

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Jun 19, 2009·Updated Jul 28, 2014

In Brief

A Phase 4 clinical trial evaluating Reveal® XT Insertable Cardiac Monitor for Cryptogenic Symptomatic Transient Ischemic Attack and Cryptogenic Ischemic Stroke. Completed, enrolled 447 participants across 55 sites in 14 countries.

Detailed Summary

The 2006 American Heart Association / American Stroke Association Council on Stroke Guidelines for Prevention of Stroke in Patients With Ischemic Stroke or Transient Ischemic recommended that patients with cryptogenic stroke take antithrombotic drugs (i.e. aspirin) in order to prevent a second stroke. When a stroke patient is found to have atrial fibrillation (AF), the guidelines recommend oral anticoagulation due to its superior efficacy over aspirin for stroke prevention. Physicians can best optimize the use of medicines only if they can precisely and correctly diagnose a patient's AF. The purpose of this study is to evaluate the time to first AF by 6 months' continuous rhythm monitoring versus control treatment in subjects with a recent cryptogenic stroke or Transient Ischemic Attack (TIA) without history of AF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain, Sweden, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 19, 2009
Enrollment StartJun 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 17.0 years ago

Interventions

Reveal® XT Insertable Cardiac Monitordevice

The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia.