Atrial Fibrillation Clinical Trial
Official title:
Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT.
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.
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
60-100 centers primarily in Europe. It is expected that 800-1000 patients will be enrolled.
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Time Perspective: Prospective
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