PANORAMA Observational Study
- Conditions
- Heart FailureSinus Node DiseaseArrhythmiaHeart Block
- Interventions
- Device: Cardiac Rhythm Management device
- Registration Number
- NCT00382525
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8586
- (To be) implanted with a Medtronic market-released cardiac device,
- Signed Patient Data Release Form.
- Unwillingness or inability to cooperate or give voluntary consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Cardiac Rhythm Management device Cardiac Rhythm Management device Patients receiving a Medtronic Cardiac Rhythm Device, worldwide
- Primary Outcome Measures
Name Time Method To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
A.Z. Klina
🇧🇪Brasschaat, Belgium
Novosibirsk Regional Cardio Center
🇷🇺Novosibirsk, Russian Federation
Rostov area hospital
🇷🇺Rostov-on-Don, Russian Federation
Scientific Research Insitute of Cardiology
🇷🇺Tomsk, Russian Federation
Tyumen Cardiology Center
🇷🇺Tyumen, Russian Federation
Regional Hospital #1
🇷🇺Vladivostok, Russian Federation
Scientific Research Institute of Circ. Pathology
🇷🇺Novosibirsk, Russian Federation
C.H.I.R.E.C. - Site de Braine la Alleud
🇧🇪Braine l'Alleud, 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
Cardiovascular Institute Dedinje
Beograd (Belgrade), Former Serbia and Montenegro
Clinical Centre Nis
Nis, Former Serbia and Montenegro
Max Devki Devi Foundation
🇮🇳New Delhi, India
Instit. of Cardiovasc. Diseases, Univ. of Novi Sad
Sremska Kamenica, Former Serbia and Montenegro
S.A.L. Hospital and Medical Institute
🇮🇳Ahmedabad, India
Chest Disease Hospital
🇰🇼Safat, Kuwait
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
I.P. Pavlovs State Medical University- Hospital #2
🇷🇺St. Petersburg, Russian Federation
Medical Academy of Postgraduate Studies
🇷🇺St. Petersburg, Russian Federation
Volgograd cardio center
🇷🇺Volgograd, Russian Federation
Sweidan Raed King Fahd Armed Forces Hospital
🇸🇦Jeddah, Saudi Arabia