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

Tracking Information

Start Date  ICMJEJanuary 2005
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
Original Primary Outcome Measures ICMJE 
Change HistoryComplete list of historical versions of study NCT00382525 on Archive Site
Current Secondary Outcome Measures ICMJE 
Original Secondary Outcome Measures ICMJE 

Descriptive Information

Brief Title  ICMJEPANORAMA Observational Study
Official Title  ICMJEPhase 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 PhasePhase IV
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJE
  • Arrhythmia
  • Cardiac Pacemaker, Artificial
  • Defibrillators, Implantable
Intervention  ICMJEDevice: Cardiac Pacemaker, Defibrillator, pacemaker lead

Recruitment Information

Estimated Enrollment  ICMJE10000
Estimated Completion DateJanuary 2018
Primary Completion Date 
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,
  • Enrollment outside a 30-day window from the planned/performed implant.
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Antoine Cuijpers+31.433.56 ext
Contact: Marc Messier+31.433.56 ext
Location Countries  ICMJEBelgium,   Former Serbia and Montenegro,   India,   Kuwait,   Russian Federation,   Saudi Arabia

Administrative Information

Responsible Party 
Study ID Numbers  ICMJEVersion 1 April 25th, 2005
Study Sponsor  ICMJEMedtronic Bakken Research Center
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Art PilmeyerMedtronic Bakken Research Center
Information Provided ByMedtronic Bakken Research Center