NCT00382525

PANORAMA Observational Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8,586 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmia
• Sinus Node Disease
• Heart Failure
• Heart Block

Interventions

Type	Name	Description
DEVICE	Cardiac Rhythm Management device

Timeline

• Start date: 2005-01-01
• Primary completion: 2012-10-01
• Completion: 2013-03-01
• First posted: 2006-09-29
• Last updated: 2025-07-03

Locations

27 sites across 6 countries: Belgium, India, Kuwait, Russia, Saudi Arabia, Serbia and Montenegro