PANORAMA Observational Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Cardiac Rhythm Management device Patients receiving a Medtronic Cardiac Rhythm Device, worldwide |
Device: Cardiac Rhythm Management device
|
Outcome Measures
Primary Outcome Measures
- To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices [2013]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
(To be) implanted with a Medtronic market-released cardiac device,
-
Signed Patient Data Release Form.
Exclusion Criteria:
- Unwillingness or inability to cooperate or give voluntary consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | C.H.I.R.E.C. - Site de Braine la Alleud | Braine l'Alleud | Belgium | ||
| 2 | A.Z. Klina | Brasschaat | Belgium | ||
| 3 | St. Vincentius-Campus St. Jozef | Mortsel | Belgium | ||
| 4 | Centre de Medecine Cardiologique | Namur | Belgium | ||
| 5 | Centre Hosp. Régional du Tournaisis- Site Hopital | Tournai | Belgium | ||
| 6 | Hôpital Notre Dame de Tournai | Tournai | Belgium | ||
| 7 | Cardiovascular Institute Dedinje | Beograd (Belgrade) | Former Serbia and Montenegro | ||
| 8 | Clinical Centre Nis | Nis | Former Serbia and Montenegro | ||
| 9 | Instit. of Cardiovasc. Diseases, Univ. of Novi Sad | Sremska Kamenica | Former Serbia and Montenegro | ||
| 10 | S.A.L. Hospital and Medical Institute | Ahmedabad | India | ||
| 11 | Max Devki Devi Foundation | New Delhi | India | ||
| 12 | Chest Disease Hospital | Safat | Kuwait | ||
| 13 | Sverlovsk Regional Clinical Hospital N1 | Ekaterinburg | Russian Federation | ||
| 14 | Regional Clinical Cardio Center | Khabarovsk | Russian Federation | ||
| 15 | FGU Moscow SRC of Pediatrics & Childrens Surgery | Moscow | Russian Federation | ||
| 16 | Scientific Center of Heart Surgery by A.N. Bakulev | Moscow | Russian Federation | ||
| 17 | Scientific Research Institute of Transplantology | Moscow | Russian Federation | ||
| 18 | Novosibirsk Regional Cardio Center | Novosibirsk | Russian Federation | ||
| 19 | Scientific Research Institute of Circ. Pathology | Novosibirsk | Russian Federation | ||
| 20 | Rostov area hospital | Rostov-on-Don | Russian Federation | ||
| 21 | I.P. Pavlovs State Medical University- Hospital #2 | St. Petersburg | Russian Federation | ||
| 22 | Medical Academy of Postgraduate Studies | St. Petersburg | Russian Federation | ||
| 23 | Scientific Research Insitute of Cardiology | Tomsk | Russian Federation | ||
| 24 | Tyumen Cardiology Center | Tyumen | Russian Federation | ||
| 25 | Regional Hospital #1 | Vladivostok | Russian Federation | ||
| 26 | Volgograd cardio center | Volgograd | Russian Federation | ||
| 27 | Sweidan Raed King Fahd Armed Forces Hospital | Jeddah | Saudi Arabia |
Sponsors and Collaborators
- Medtronic Bakken Research Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Version 1 April 25th, 2005