Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (CRYSTAL-AF)
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ClinicalTrials.gov Identifier: NCT00924638 |
Recruitment Status
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Completed
First Posted
: June 19, 2009
Results First Posted
: July 28, 2014
Last Update Posted
: July 28, 2014
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Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
- Study Details
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Tracking Information | |||||||||||||||||||||||||
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First Submitted Date ICMJE | June 17, 2009 | ||||||||||||||||||||||||
First Posted Date ICMJE | June 19, 2009 | ||||||||||||||||||||||||
Results First Submitted Date | June 26, 2014 | ||||||||||||||||||||||||
Results First Posted Date | July 28, 2014 | ||||||||||||||||||||||||
Last Update Posted Date | July 28, 2014 | ||||||||||||||||||||||||
Study Start Date ICMJE | June 2009 | ||||||||||||||||||||||||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
AF Detection Rate Within 6 Months [ Time Frame: 6 months ] Percentage of subjects with AF detected within 6 months of follow-up
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Original Primary Outcome Measures ICMJE |
Time to first documented episode of AF [ Time Frame: 6 months ] | ||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00924638 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||
Brief Title ICMJE | Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke | ||||||||||||||||||||||||
Official Title ICMJE | CRYptogenic STroke And underLying AF Trial | ||||||||||||||||||||||||
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 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. | ||||||||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||
Study Phase | Phase 4 | ||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | 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.
Other Name: Reveal® XT |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||
Actual Enrollment ICMJE |
447 | ||||||||||||||||||||||||
Original Estimated Enrollment ICMJE |
450 | ||||||||||||||||||||||||
Actual Study Completion Date | May 2013 | ||||||||||||||||||||||||
Actual Primary Completion Date | May 2013 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 40 Years and older (Adult, Senior) | ||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
Listed Location Countries ICMJE | Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain, Sweden, United States | ||||||||||||||||||||||||
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Administrative Information | |||||||||||||||||||||||||
NCT Number ICMJE | NCT00924638 | ||||||||||||||||||||||||
Other Study ID Numbers ICMJE | CRYSTAL-AF | ||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||||||||||||||
Responsible Party | Medtronic Cardiac Rhythm and Heart Failure | ||||||||||||||||||||||||
Study Sponsor ICMJE | Medtronic Cardiac Rhythm and Heart Failure | ||||||||||||||||||||||||
Collaborators ICMJE | Medtronic Bakken Research Center | ||||||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Medtronic Cardiac Rhythm and Heart Failure | ||||||||||||||||||||||||
Verification Date | January 2014 | ||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |