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PANORAMA Observational Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00382525
First Posted: September 29, 2006
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Bakken Research Center
September 28, 2006
September 29, 2006
September 6, 2017
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 ]

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
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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
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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
Sexes Eligible for Study: All
Child, Adult, Senior
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
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Medtronic Bakken Research Center
Medtronic Bakken Research Center
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Not Provided
Medtronic Bakken Research Center
September 2017