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
  Purpose

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 Intervention Phase
Arrhythmia
Sinus Node Disease
Heart Failure
Heart Block
Device: Cardiac Rhythm Management device
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • 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.



Enrollment: 8586
Study Start Date: January 2005
Study Completion Date: March 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Cardiac Rhythm Management device
Patients receiving a Medtronic Cardiac Rhythm Device, worldwide
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving market released Medtronic Cardiac Rhythm device, worldwide

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382525

Locations
Belgium
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
Hôpital Notre Dame de Tournai
Tournai, Belgium
Centre Hosp. Régional du Tournaisis- Site Hopital
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
India
S.A.L. Hospital and Medical Institute
Ahmedabad, India
Max Devki Devi Foundation
New Delhi, India
Kuwait
Chest Disease Hospital
Safat, Kuwait
Russian Federation
Sverlovsk Regional Clinical Hospital N1
Ekaterinburg, Russian Federation
Regional Clinical Cardio Center
Khabarovsk, Russian Federation
Scientific Center of Heart Surgery by A.N. Bakulev
Moscow, Russian Federation
Scientific Research Institute of Transplantology
Moscow, Russian Federation
FGU Moscow SRC of Pediatrics & Childrens Surgery
Moscow, Russian Federation
Scientific Research Institute of Circ. Pathology
Novosibirsk, Russian Federation
Novosibirsk Regional Cardio Center
Novosibirsk, Russian Federation
Rostov area hospital
Rostov-on-Don, Russian Federation
Medical Academy of Postgraduate Studies
St. Petersburg, Russian Federation
I.P. Pavlovs State Medical University- Hospital #2
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
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00382525     History of Changes
Other Study ID Numbers: Version 1 April 25th, 2005
Study First Received: September 28, 2006
Last Updated: April 8, 2013
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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

Additional relevant MeSH terms:
Heart Failure
Heart Block
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014