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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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| Measure | Description | Time Frame |
|---|---|---|
| descriptive: clinical indications for Reveal XT | To describe the patient population implanted with a Reveal XT for arrhythmia diagnosis and monitoring | 2008-2012 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients currently implanted with, or who will be implanted with a Reveal XT Insertable Cardiac Monitor for arrhythmia diagnosis or monitoring.
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| Name | Affiliation | Role |
|---|---|---|
| Guido Rieger, MD | Medtronic Bakken Research Center BV | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Elisabethinen | Linz | Austria | ||||
| Universitätsklinik für Innere Medizin |
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| Vienna |
| Austria |
| Klinkum Wels-Grieskirchen GmbH | Wels | Austria |
| Republican Scientific Practical Center | Minsk | Belarus |
| Fakultni nemocnice Brno | Brno | Czechia |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia |
| Kardiologicka ambulance | Ostrava | Czechia |
| Tampere University Hospital | Tampere | Finland |
| Zentralklinik Bad Berka | Bad Berka | Germany |
| St.-Marien-Hospital | Bonn-Venusberg | Germany |
| Kardiologische Praxis | Burg | Germany |
| Klinikum Coburg | Coburg | Germany |
| Kardiologische Praxis | Dessau | Germany |
| Herzzentrum Dresden | Dresden | Germany |
| Kardiocentrum | Frankfurt | Germany |
| Universitatsklinikum | Freiburg im Breisgau | Germany |
| St. Johannes Hospital | Hagen | Germany |
| Universitares Herzzentrum | Hamburg | Germany |
| Medizinische Hochshule | Hanover | Germany |
| Asklepios Klinik | Harburg | Germany |
| Uniklinik Homburg - Klinik fur Innere Medizin III | Homburg | Germany |
| Herzzentrum, University of Leipzig | Leipzig | Germany |
| Klinik Augustinum | München | Germany |
| Klinikum der Universität München-Großhadern (LMU) | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Klinikum Nürnberg Süd | Nuremberg | Germany |
| St. Martinus Hospital | Olpe | Germany |
| DRK-Krankenhaus Mölln-Ratzeburg | Ratzeburg | Germany |
| Krankenhaus Barmherzige Brueder | Regensburg | Germany |
| Krankenhaus Reinbek, St.-Adolf-Stift | Reinbek | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | Germany |
| Azienda Ospedaliera Universitaria Careggi | Florence | Italy |
| Gelre Apeldoorn | Apeldoorn | Netherlands |
| Ziekenhuis De Tjongerschans | Heerenveen | Netherlands |
| Bethesda Ziekenhuis | Hoogeveen | Netherlands |
| Westfries Gasthuis | Hoorn | Netherlands |
| Medisch Centrum Leeuwarden | Leeuwarden | Netherlands |
| Vlietland Ziekenhuis | Schiedam | Netherlands |
| Maasland Ziekenhuis | Sittard | Netherlands |
| Diakonessenhuis Utrecht | Utrecht | Netherlands |
| Centro Hospitalar do Porto - Hospital de Santo Antonio | Porto | Portugal |
| Scientific Research Center of Cardio Vascular Surgery by A.N. Bakulev | Moscow | Russia |
| State Research Institute of Circulation Pathology | Novosibirsk | Russia |
| Almazov Federeal Heart, Blood and Endocrinology Centre | Saint Petersburg | Russia |
| Tyumen Cardiology Centre | Tyumen | Russia |
| Arytmologicke oddelenie VUSCH | Košice | Slovakia |
| University Medical Center Ljubljana | Ljubljana | Slovenia |
| Complejo Hospitalario Universitario de Vigo | Vigo | Spain |
| University Hospital Örebro | Örebro | Sweden |
| Hopital Cantonal de Fribourg | Fribourg | Switzerland |
| Hopital Cantonal Universitaires de Geneve | Geneva | Switzerland |
| Hopital de Pourtales de Neuchatel | Neuchâtel | Switzerland |
| Hopital de Sion CHCVS | Sion | Switzerland |
| UniversitatsSpital | Zurich | Switzerland |
| Sheikh Khalifa Medical Center | Abu Dhabi | United Arab Emirates |
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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