PANORAMA Observational Study

Medtronic

Status: Completed

Conditions: Sinus Node Disease; Arrhythmia; Heart Failure; Heart Block

Treatments: Device: Cardiac Rhythm Management device

Study type: Observational

Funder types: Industry

Identifiers

NCT00382525

Version 1 April 25th, 2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,586 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

8,586 participants in 1 patient group

Patients with Cardiac Rhythm Management device

Description:

Patients receiving a Medtronic Cardiac Rhythm Device, worldwide

Treatment:

Device: Cardiac Rhythm Management device