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Sponsored by: |
Medtronic BRC |
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Information provided by: | Medtronic BRC |
ClinicalTrials.gov Identifier: | NCT00680550 |
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.
Condition |
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Atrial Fibrillation Risk of Cardiac Arrhythmias |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Indications for Diagnosis, Arrhythmia and Monitoring of Reveal XT. |
Estimated Enrollment: | 500 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Improving the diagnosis and management of cardiac rhythm disturbances remains a major challenge for phycisians. 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, multi-center 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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients currently implanted with, or who will be implanted with a Reveal XT Insertable Cardiac Monitor for arrhythmia diagnosis or monitoring.
Inclusion Criteria:
Exclusion Criteria:
Contact: Guido Rieger, MD | 31 (0)43 35 66 566 ext 6844 | guido.rieger@medtronic.com |
Germany | |
Kardiologische Praxis Dres. Med. Kruck/Krause-Allmendinger/Simon/Bosch | Recruiting |
Ludwigsburg, Germany | |
Principal Investigator: R. Bosch, MD |
Study Chair: | Guido Rieger, MD | Medtronic Bakken Research Center |
Responsible Party: | Medtronic ( Vitatron B.V. ) |
Study ID Numbers: | CMD 466 |
Study First Received: | May 15, 2008 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00680550 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Atrial Fibrillation Risk of cardiac Arrhythmias Loop recorder |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |