Status:
COMPLETED
Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Cryptogenic Symptomatic Transient Ischemic Attack
Cryptogenic Ischemic Stroke
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
Exclusion
- Known etiology of TIA or stroke.
- Untreated hyperthyroidism.
- Myocardial infarction less than 1 month prior to stroke or TIA.
- Coronary bypass grafting less than 1 month prior to stroke or TIA.
- Valvular disease requiring immediate surgical intervention.
- History of AF or atrial flutter.
- Patent Foramen Ovale (PFO) and PFO is or was an indication to start oral anticoagulation (OAC).
- Permanent indication for OAC at enrollment.
- Permanent contra-indication for OAC.
- Included in another clinical trial.
- Life expectancy less than 1 year.
- Pregnant.
- Indicated for Implantable Pulse Generator (IPG), Implantable Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT) or an implantable hemodynamic monitoring system.
- Not fit, unable or unwilling to follow the required procedures of the protocol.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT00924638
Start Date
June 1 2009
End Date
May 1 2013
Last Update
July 28 2014
Active Locations (55)
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1
El Camino Hospital
Mountain View, California, United States
2
South Denver Cardiology / Swedish Medical Center
Denver, Colorado, United States
3
Northwestern Memorial Hospital
Chicago, Illinois, United States
4
Iowa Heart / Ruan Neurology
Des Moines, Iowa, United States