Tracking Information
Start Date ICMJE | April 2008 |
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Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00680550 on ClinicalTrials.gov Archive Site |
Descriptive Information
Brief Title ICMJE | INSIGHT (R)XT. Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT |
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Official Title ICMJE | Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT. |
Brief Summary | To describe the clinical indications for Reveal XT in diagnosis and continuous monitoring of arrhythmia and to explore the clinical applications and outcome of arrhythmia monitoring on patient care. |
Detailed Description | Improving the diagnosis and management of cardiac rhythm disturbances remains a major challenge for physicians. Limitations of current cardiac arrhythmia monitoring using ECG, holters or event recorders are that these methods are non-continuous and/or automatic arrhythmia detection is often impossible. The Medtronic Reveal XT Insertable Cardiac Monitor is a programmable device which continuously monitors the patient's subcutaneous ECG and provides information regarding arrhythmia episodes, long term trending of AF burden, patient's activity and heart rate variability. The Reveal XT records cardiac information in response to patient activation and automatically detected arrhythmias thereby offering advantages over conventional tools for long-term arrhythmia monitoring with regard to compliance and recording time. The clinical applications for Reveal XT are varied. Diagnostic, arrhythmia monitoring and arrhythmia management functions can be discriminated. This study is a prospective, observational, multicenter international post-market study. The results of this study will describe the different patient groups for which the Reveal XT is being used for the diagnosis and monitoring of various cardiac arrhythmias. This study will also collect data regarding the clinical consequences of using the Reveal XT and the influence of Reveal XT data on clinical care pathways. The physician as well as the patient's satisfaction with the device will be evaluated. The study will be conducted in 80-100 centers primarily in Europe. It is expected that 500 patients will be enrolled. |
Study Phase | |
Study Type ICMJE | Observational |
Study Design ICMJE | Other, Prospective |
Condition ICMJE |
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Recruitment Information
Estimated Enrollment ICMJE | 500 | ||||||||
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Estimated Completion Date | September 2011 | ||||||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Austria, Czech Republic, Germany, Netherlands, Russian Federation, Switzerland, United Arab Emirates |
Administrative Information
NCT ID ICMJE | NCT00680550 | ||||
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Responsible Party | Medtronic Bakken Research Center B.V., Medtronic | ||||
Study ID Numbers ICMJE | CMD 466 | ||||
Study Sponsor ICMJE | Medtronic BRC | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Medtronic BRC |