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To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pacemakers and cardioverter defibrillators (both with or without cardiac resynchronization therapy), implantable loop recorders and leads used within their intended use.
Clinical variables will be analyzed in relation to device-based data and diagnostics.
PANORAMA will collect a large database of device behavior, for instance to monitor long term behavior of device features, technical reliability and longevity, as well as to allow studying device performance in different subgroups of patients. Larger databases are often essential for formulating and testing study hypotheses for prospective (randomized) trials. While it may depend on specific objectives for individual devices, reliable assessment of device performance over longer periods and in broad patient populations typically requires a study population from a few hundred to a few thousand patients. PANORAMA collects acute and chronic patient and device data in a large population during routine usage of the device, without specific study interventions, and always within the approved intended use of the device.
In the past, observational studies were designed and conducted specifically on a device-by-device case. PANORAMA avoids the redesign of the same set of data. It establishes a core database which can be expanded with substudies creating more detailed data sets for particular CRDM devices/features.
PANORAMA will be open for inclusion to any patient (to be) implanted with a CRDM device. It shall be suitable for current and upcoming CRDM devices implanted in patients. It will serve as an epidemiological tool designed to stratify morbidity and mortality of all cardiac diseases treated by implantable CRDM devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Cardiac Rhythm Management device | Patients receiving a Medtronic Cardiac Rhythm Device, worldwide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Rhythm Management device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices | To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic implantable pulse generators [IPG] and implantable cardioverter defibrillators [ICD] both with or without cardiac resynchronization therapy [+/- CRT], implantable loop recorders [ILR] and leads implanted within intended use. Stratified per country, per pathology, per indication and per device type. | 2013 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving market released Medtronic Cardiac Rhythm device, worldwide
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.H.I.R.E.C. - Site de Braine la Alleud | Braine-l'Alleud | Belgium | ||||
| A.Z. Klina |
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| Brasschaat |
| Belgium |
| St. Vincentius-Campus St. Jozef | Mortsel | Belgium |
| Centre de Medecine Cardiologique | Namur | Belgium |
| Centre Hosp. Régional du Tournaisis- Site Hopital | Tournai | Belgium |
| Hôpital Notre Dame de Tournai | Tournai | Belgium |
| S.A.L. Hospital and Medical Institute | Ahmedabad | India |
| Max Devki Devi Foundation | New Delhi | India |
| Chest Disease Hospital | Safat | Kuwait |
| Regional Clinical Cardio Center | Khabarovsk | Russia |
| FGU Moscow SRC of Pediatrics & Childrens Surgery | Moscow | Russia |
| Scientific Center of Heart Surgery by A.N. Bakulev | Moscow | Russia |
| Scientific Research Institute of Transplantology | Moscow | Russia |
| Novosibirsk Regional Cardio Center | Novosibirsk | Russia |
| Scientific Research Institute of Circ. Pathology | Novosibirsk | Russia |
| Rostov area hospital | Rostov-on-Don | Russia |
| I.P. Pavlovs State Medical University- Hospital #2 | Saint Petersburg | Russia |
| Medical Academy of Postgraduate Studies | Saint Petersburg | Russia |
| Scientific Research Insitute of Cardiology | Tomsk | Russia |
| Tyumen Cardiology Center | Tyumen | Russia |
| Regional Hospital #1 | Vladivostok | Russia |
| Volgograd cardio center | Volgograd | Russia |
| Sverlovsk Regional Clinical Hospital N1 | Yekaterinburg | Russia |
| Sweidan Raed King Fahd Armed Forces Hospital | Jeddah | Saudi Arabia |
| Cardiovascular Institute Dedinje | Beograd (Belgrade) | Serbia and Montenegro |
| Clinical Centre Nis | Nis | Serbia and Montenegro |
| Instit. of Cardiovasc. Diseases, Univ. of Novi Sad | Sremska Kamenica | Serbia and Montenegro |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D012804 | Sick Sinus Syndrome |
| D006333 | Heart Failure |
| D006327 | Heart Block |
| D001919 | Bradycardia |
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001146 | Arrhythmia, Sinus |
| D000075224 | Cardiac Conduction System Disease |
| D013610 | Tachycardia |
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