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PANORAMA Observational Study
This study is currently recruiting participants.
Verified by Medtronic Bakken Research Center, April 2008
Sponsored by: Medtronic Bakken Research Center
Information provided by: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00382525
  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
Cardiac Pacemaker, Artificial
Defibrillators, Implantable
Device: Cardiac Pacemaker, Defibrillator, pacemaker lead
Phase IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices

Further study details as provided by Medtronic Bakken Research Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 10000
Study Start Date: January 2005
Estimated Study Completion Date: January 2018
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
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,
  • Enrollment outside a 30-day window from the planned/performed implant.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382525

Contacts
Contact: Antoine Cuijpers +31.433.56 ext 6831 antoine.cuijpers@medtronic.com
Contact: Marc Messier +31.433.56 ext 6715 marc.messier@medtronic.com

Locations
Belgium
Hôpital Notre Dame de Tournai Recruiting
Tournai, Belgium
Contact: Hamoir Vincent            
Principal Investigator: Hamoir Vincent            
Centre de Medecine Cardiologique Recruiting
Namur, Belgium
Contact: Eric Mievis            
Principal Investigator: Eric Mievis            
a.Z. KLINA Recruiting
Brasschaat, Belgium
Contact: Johan Salembier            
Principal Investigator: Johan Salembier            
C.H.I.R.E.C. - Site de Braine la Alleud Recruiting
Braine l'Alleud, Belgium
Contact: Janik Van der Auwera            
Contact: Bernard Cosyns            
Principal Investigator: Janik Van der Auwera            
Centre Hosp. Régional du Tournaisis- Site Hopital Recruiting
Tournai, Belgium
Contact: Raymond Gilles            
Principal Investigator: Raymond Gilles            
St. Vincentius-Campus St. Jozef Recruiting
Mortsel, Belgium
Contact: Dimitri Vermander            
Principal Investigator: Dimitri Vermander            
India
S.A.L. Hospital and Medical Institute Recruiting
Ahmedabad, India
Contact: Ajay Naik            
Principal Investigator: Ajay Naik            
Max Devki Devi Foundation Recruiting
New Delhi, India
Contact: Viveka Kumar            
Principal Investigator: Viveka Kumar            
Kuwait
Chest Disease Hospital Recruiting
Safat, Kuwait
Contact: Fawziah Al-Kandari            
Principal Investigator: Fawziah Al-Kandari            
Russian Federation
Regional Clinical Cardio Center Recruiting
Khabarovsk, Russian Federation
Contact: Vladimir Bondar            
Principal Investigator: Vladimir Bondar            
Scientific Research Institute of Transplantology Recruiting
Moscow, Russian Federation
Contact: Dmitry Shumakov            
Principal Investigator: Dmitry Shumakov            
Novosibirsk Regional Cardio Center Recruiting
Novosibirsk, Russian Federation
Contact: Sergey Zenin            
Principal Investigator: Sergey Zenin            
Scientific Center of Heart Surgery by A.N. Bakulev Recruiting
Moscow, Russian Federation
Contact: Olga Bokeria            
Principal Investigator: Olga Bokeria            
Scientific Research Insitute of Cardiology Recruiting
Tomsk, Russian Federation
Contact: Sergey Popov            
Principal Investigator: Sergey Popov            
Scientific Research Institute of Circ. Pathology Recruiting
Novosibirsk, Russian Federation
Contact: Evgeniy Pokushalov            
Principal Investigator: Evgeniy Pokushalov            
Volgograd cardio center Recruiting
Volgograd, Russian Federation
Contact: Fedor Nemchuk            
Principal Investigator: Fedor Nemchuk            
Rostov area hospital Recruiting
Rostov-on-Don, Russian Federation
Contact: Georgiy Chudinov            
Principal Investigator: Georgiy Chudinov            
Tyumen Cardiology Center Recruiting
Tyumen, Russian Federation
Contact: Vadim Kuznetsov            
Principal Investigator: Vadim Kuznetsov            
Sverlovsk Regional Clinical Hospital N1 Recruiting
Ekaterinburg, Russian Federation
Contact: Sergey Mikhaylov            
Principal Investigator: Sergey Mikhaylov            
Regional Hospital #1 Recruiting
Vladivostok, Russian Federation
Contact: Victor Britcine            
Principal Investigator: Victor Britcine            
I.P. Pavlovs State Medical University- Hospital #2 Recruiting
St. Petersburg, Russian Federation
Contact: Dmitry S. Lebedev            
Principal Investigator: Dmitry Lebedev            
Medical Academy of Postgraduate Studies Recruiting
St. Petersburg, Russian Federation
Contact: Pavel Krasnoperov            
Principal Investigator: Pavel Krasnoperov            
FGU Moscow SRC of Pediatrics & Childrens Surgery Recruiting
Moscow, Russian Federation
Contact: Sergey Termosesov            
Principal Investigator: Sergey Termosesov            
Saudi Arabia
Sweidan Raed King Fahd Armed Forces Hospital Recruiting
Jeddah, Saudi Arabia
Contact: Raed Sweidan            
Principal Investigator: Raed Sweidan            
Serbia and Montenegro
Instit. of Cardiovasc. Diseases, Univ. of Novi Sad Recruiting
Sremska Kamenica, Serbia and Montenegro
Contact: Dragan Kovacevic            
Principal Investigator: Dragan Kovacevic            
Cardiovascular Institute Dedinje Recruiting
Beograd (Belgrade), Serbia and Montenegro
Contact: Lazar Angelkov            
Principal Investigator: Lazar Angelkov            
Clinical Centre Nis Recruiting
Nis, Serbia and Montenegro
Contact: Zoran Perisic            
Principal Investigator: Zoran Perisic            
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Study Director: Art Pilmeyer Medtronic Bakken Research Center
  More Information

Study ID Numbers: Version 1 April 25th, 2005
Study First Received: September 28, 2006
Last Updated: April 23, 2008
ClinicalTrials.gov Identifier: NCT00382525  
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
Pacemaker
Implantable Cardioverter Defibrillator
Loop recorder
Registry
Epidemiology

Study placed in the following topic categories:
Heart Diseases
Tachycardia
Bradycardia
Paroxysmal ventricular fibrillation
Atrial Fibrillation
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009