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Sponsored by: |
Medtronic Bakken Research Center |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00382525 |
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 |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices |
Estimated Enrollment: | 10000 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | January 2018 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Antoine Cuijpers | +31.433.56 ext 6831 | antoine.cuijpers@medtronic.com |
Contact: Marc Messier | +31.433.56 ext 6715 | marc.messier@medtronic.com |
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 |
Study Director: | Art Pilmeyer | Medtronic Bakken Research Center |
Study ID Numbers: | Version 1 April 25th, 2005 |
Study First Received: | September 28, 2006 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00382525 History of Changes |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Bradyarrhythmia Atrial Fibrillation Ventricular Tachycardia Ventricular Fibrillation Pacemaker |
Implantable Cardioverter Defibrillator Loop recorder Registry Epidemiology |
Paroxysmal Ventricular Fibrillation Heart Diseases Tachycardia Bradycardia |
Atrial Fibrillation Tachycardia, Ventricular Ventricular Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac |