PANORAMA Observational Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00382525
First received: September 28, 2006
Last updated: April 8, 2013
Last verified: April 2013

September 28, 2006
April 8, 2013
January 2005
October 2012   (final data collection date for primary outcome measure)
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices [ Time Frame: 2013 ] [ Designated as safety issue: No ]

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.

Not Provided
Complete list of historical versions of study NCT00382525 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
PANORAMA Observational Study
Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients receiving market released Medtronic Cardiac Rhythm device, worldwide

  • Arrhythmia
  • Sinus Node Disease
  • Heart Failure
  • Heart Block
Device: Cardiac Rhythm Management device
Patients with Cardiac Rhythm Management device
Patients receiving a Medtronic Cardiac Rhythm Device, worldwide
Intervention: Device: Cardiac Rhythm Management device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8586
March 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Former Serbia and Montenegro,   India,   Kuwait,   Russian Federation,   Saudi Arabia
 
NCT00382525
Version 1 April 25th, 2005
No
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Not Provided
Medtronic Bakken Research Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP