Arrhythmia, Heart Block, Heart Failure, Sinus Node Disease
Conditions
Keywords
Bradyarrhythmia, Atrial Fibrillation, Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, Loop recorder, Registry
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.
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.
Interventions
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, India, Kuwait, Russia, Saudi Arabia, Serbia and Montenegro
Outcome results
None listed