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

History of Changes

Tracking Information
First Received Date ^ICMJE	September 28, 2006
Last Updated Date	April 8, 2013
Start Date ^ICMJE	January 2005
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2013)	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.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00382525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PANORAMA Observational Study
Official Title ^ICMJE	Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices
Brief 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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients receiving market released Medtronic Cardiac Rhythm device, worldwide
Condition ^ICMJE	Arrhythmia Sinus Node Disease Heart Failure Heart Block
Intervention ^ICMJE	Device: Cardiac Rhythm Management device
Study Group/Cohort (s)	Patients with Cardiac Rhythm Management device Patients receiving a Medtronic Cardiac Rhythm Device, worldwide Intervention: Device: Cardiac Rhythm Management device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8586
Completion Date	March 2013
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Former Serbia and Montenegro, India, Kuwait, Russian Federation, Saudi Arabia

Administrative Information
NCT Number ^ICMJE	NCT00382525
Other Study ID Numbers ^ICMJE	Version 1 April 25th, 2005
Has Data Monitoring Committee	No
Responsible Party	Medtronic Bakken Research Center
Study Sponsor ^ICMJE	Medtronic Bakken Research Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Bakken Research Center
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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