PANORAMA Observational Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices

Conditions
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Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block

Intervention / Treatment
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* Device: Cardiac Rhythm Management device


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Cardiac Rhythm Management device<br>Patients receiving a Medtronic Cardiac Rhythm Device, worldwide | Device: Cardiac Rhythm Management device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Bradyarrhythmia, Atrial Fibrillation, Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, Loop recorder