Study of Continuous Cardiac Monitoring to Assess Atrial Fibrillation After Cryptogenic Stroke (CRYSTAL-AF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00924638
First received: June 17, 2009
Last updated: June 26, 2014
Last verified: January 2014
Results First Received: June 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Cryptogenic Symptomatic Transient Ischemic Attack
Cryptogenic Ischemic Stroke
Intervention: Device: Reveal® XT Insertable Cardiac Monitor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 447 subjects were enrolled in 55 study centers from 14 countries in North America and Europe, during the recruitment period of June 2009 to April 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 6 enrolled subjects were exited from the study prior to randomization due to: Eligibility criteria not met (n=4), and Subject withdrew consent (n=2).

Reporting Groups
  Description
Continuous Monitoring

Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor

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.

Control Arm Follow-up at the same frequency, but with no Insertable Cardiac Monitor

Participant Flow:   Overall Study
    Continuous Monitoring     Control Arm  
STARTED     221 [1]   220 [2]
COMPLETED     209 [3]   207 [3]
NOT COMPLETED     12     13  
Death                 3                 2  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 5                 7  
Physician Decision                 3                 3  
[1] Randomized to Continuous Monitoring Arm
[2] Randomized to Control Arm
[3] Completed 6 months of follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention-to-treat (ITT) population (all randomized subjects)

Reporting Groups
  Description
Continuous Monitoring

Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor

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.

Control Arm Follow-up at the same frequency, but with no Insertable Cardiac Monitor
Total Total of all reporting groups

Baseline Measures
    Continuous Monitoring     Control Arm     Total  
Number of Participants  
[units: participants]
  221     220     441  
Age  
[units: years]
Mean ± Standard Deviation
  61.6  ± 11.4     61.4  ± 11.3     61.5  ± 11.3  
Gender  
[units: participants]
     
Female     79     82     161  
Male     142     138     280  
Region of Enrollment  
[units: participants]
     
United States     80     66     146  
Slovakia     1     3     4  
Greece     1     0     1  
Finland     0     2     2  
Spain     0     5     5  
Austria     23     16     39  
Italy     28     31     59  
France     17     17     34  
Canada     3     6     9  
Belgium     14     27     41  
Denmark     3     3     6  
Germany     39     32     71  
Netherlands     12     11     23  
Sweden     0     1     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   AF Detection Rate Within 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   AF Detection Rate Within 12 Months   [ Time Frame: 12 months ]

3.  Secondary:   Incidence of Recurrent Stroke or TIA (Transient Ischemic Attack)   [ Time Frame: 12 months ]

4.  Secondary:   Use of Oral Anticoagulation (OAC) Drugs   [ Time Frame: 12 months ]

5.  Secondary:   Use of Antiarrhythmic Drugs   [ Time Frame: 12 months ]

6.  Secondary:   Health Outcome as Evaluated by EQ-5D Questionnaire   [ Time Frame: 12 months ]

7.  Secondary:   Clinical Disease Burden and Care Pathway   [ Time Frame: 12 months ]

8.  Secondary:   Impact of Patient Assistant Use on AF Diagnosis   [ Time Frame: Follow-up closure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medtronic CRDM clinical trial manager
Organization: Medtronic, Inc.
phone: 763-505-6000
e-mail: medtronicCRMtrials@medtronic.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00924638     History of Changes
Other Study ID Numbers: CRYSTAL-AF
Study First Received: June 17, 2009
Results First Received: June 26, 2014
Last Updated: June 26, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices