PANORAMA Observational Study

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. Identifier: NCT00382525
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : September 6, 2017
Information provided by (Responsible Party):
Medtronic Bakken Research Center

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.

Condition or disease Intervention/treatment
Arrhythmia Sinus Node Disease Heart Failure Heart Block Device: Cardiac Rhythm Management device

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 : Observational
Actual Enrollment : 8586 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices
Study Start Date : January 2005
Actual Primary Completion Date : October 2012
Actual Study Completion Date : March 2013

Group/Cohort Intervention/treatment
Patients with Cardiac Rhythm Management device
Patients receiving a Medtronic Cardiac Rhythm Device, worldwide
Device: Cardiac Rhythm Management device

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving market released Medtronic Cardiac Rhythm device, worldwide

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00382525

C.H.I.R.E.C. - Site de Braine la Alleud
Braine l'Alleud, Belgium
A.Z. Klina
Brasschaat, Belgium
St. Vincentius-Campus St. Jozef
Mortsel, Belgium
Centre de Medecine Cardiologique
Namur, Belgium
Centre Hosp. Régional du Tournaisis- Site Hopital
Tournai, Belgium
Hôpital Notre Dame de Tournai
Tournai, Belgium
Former Serbia and Montenegro
Cardiovascular Institute Dedinje
Beograd (Belgrade), Former Serbia and Montenegro
Clinical Centre Nis
Nis, Former Serbia and Montenegro
Instit. of Cardiovasc. Diseases, Univ. of Novi Sad
Sremska Kamenica, Former Serbia and Montenegro
S.A.L. Hospital and Medical Institute
Ahmedabad, India
Max Devki Devi Foundation
New Delhi, India
Chest Disease Hospital
Safat, Kuwait
Russian Federation
Sverlovsk Regional Clinical Hospital N1
Ekaterinburg, Russian Federation
Regional Clinical Cardio Center
Khabarovsk, Russian Federation
FGU Moscow SRC of Pediatrics & Childrens Surgery
Moscow, Russian Federation
Scientific Center of Heart Surgery by A.N. Bakulev
Moscow, Russian Federation
Scientific Research Institute of Transplantology
Moscow, Russian Federation
Novosibirsk Regional Cardio Center
Novosibirsk, Russian Federation
Scientific Research Institute of Circ. Pathology
Novosibirsk, Russian Federation
Rostov area hospital
Rostov-on-Don, Russian Federation
I.P. Pavlovs State Medical University- Hospital #2
St. Petersburg, Russian Federation
Medical Academy of Postgraduate Studies
St. Petersburg, Russian Federation
Scientific Research Insitute of Cardiology
Tomsk, Russian Federation
Tyumen Cardiology Center
Tyumen, Russian Federation
Regional Hospital #1
Vladivostok, Russian Federation
Volgograd cardio center
Volgograd, Russian Federation
Saudi Arabia
Sweidan Raed King Fahd Armed Forces Hospital
Jeddah, Saudi Arabia
Sponsors and Collaborators
Medtronic Bakken Research Center

Responsible Party: Medtronic Bakken Research Center Identifier: NCT00382525     History of Changes
Other Study ID Numbers: Version 1 April 25th, 2005
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by Medtronic Bakken Research Center:
Atrial Fibrillation
Ventricular Tachycardia
Ventricular Fibrillation
Heart Failure
Implantable Cardioverter Defibrillator
Cardiac Resynchronization Therapy
Loop recorder

Additional relevant MeSH terms:
Heart Failure
Heart Block
Sick Sinus Syndrome
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Arrhythmia, Sinus