Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (CRYSTAL-AF)
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ClinicalTrials.gov Identifier: NCT00924638 |
Recruitment Status :
Completed
First Posted : June 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cryptogenic Symptomatic Transient Ischemic Attack Cryptogenic Ischemic Stroke | Device: Reveal® XT Insertable Cardiac Monitor | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 447 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | CRYptogenic STroke And underLying AF Trial |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Continuous Monitoring
Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor
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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 |
No Intervention: Control Arm
Follow-up at the same frequency, but with no Insertable Cardiac Monitor
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- AF Detection Rate Within 6 Months [ Time Frame: 6 months ]Percentage of subjects with AF detected within 6 months of follow-up
- AF Detection Rate Within 12 Months [ Time Frame: 12 months ]Percentage of subjects with AF detected within 12 months of follow-up
- Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack) [ Time Frame: 12 months ]Percentage of subjects with recurrent stroke or TIA within 12 months of follow-up
- Use of Oral Anticoagulation (OAC) Drugs [ Time Frame: 12 months ]Percentage of subjects who were using OAC drugs at the 12 months follow-up visit
- Use of Antiarrhythmic Drugs [ Time Frame: 12 months ]Percentage of subjects who were using antiarrhythmic drugs at the 12 months follow-up visit
- Health Outcome as Evaluated by EQ-5D Questionnaire [ Time Frame: 12 months ]EQ-5D VAS (visual analog scale) quality of life score, which is a continuous measure of quality of life ranging from 0 (worst) to 100 (perfect health).
- Clinical Disease Burden and Care Pathway [ Time Frame: 12 months ]Incidence of cardiovascular (CV) or stroke/TIA related hospitalizations within 12 months
- Impact of Patient Assistant Use on AF Diagnosis [ Time Frame: Follow-up closure ]AF detection lag (days from AF occurrence to AF diagnosis) characterized by patient assistant (PA) use frequency

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recent cryptogenic symptomatic transient ischemic attack (TIA) or cryptogenic ischemic stroke.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924638

Principal Investigator: | Johannes Brachmann, MD | Klinikum Coburg, Germany | |
Principal Investigator: | Tommaso Sanna, MD | Catholic University, Italy | |
Principal Investigator: | Hans Christoph Diener, MD | Klinik für Neurologie, Essen, Germany | |
Principal Investigator: | Carlos Morillo, MD | McMaster Clinic, Hamilton, Ontario, Canada | |
Principal Investigator: | Richard Bernstein, MD, PhD | Davee Department of Neurology, Chicago, IL USA | |
Principal Investigator: | Vincenzo Di Lazzaro, MD | Catholic University Rome, Rome Italy | |
Principal Investigator: | Rod Passman, MD | Northwestern Memorial Hospital, Chicago, IL USA | |
Principal Investigator: | Marilyn Rymer, MD | St. Lukes Hospital of Kansas City, Kansas City, MI USA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medtronic Cardiac Rhythm and Heart Failure |
ClinicalTrials.gov Identifier: | NCT00924638 |
Other Study ID Numbers: |
CRYSTAL-AF |
First Posted: | June 19, 2009 Key Record Dates |
Results First Posted: | July 28, 2014 |
Last Update Posted: | July 28, 2014 |
Last Verified: | January 2014 |
atrial fibrillation cryptogenic stroke continuous monitoring implantable loop recorder insertable cardiac monitor |
Stroke Ischemic Attack, Transient Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Ischemia |