NCT00924638

Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke

CRYptogenic STroke And underLying AF Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptogenic Symptomatic Transient Ischemic Attack
• Cryptogenic Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Reveal® XT Insertable Cardiac Monitor	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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-06-19
• Last updated: 2014-07-28
• Results posted: 2014-07-28

Locations

55 sites across 14 countries: United States, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain, Sweden