Clinical trial NCT00382525: PANORAMA Observational Study
Official title: Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmia
Sinus Node Disease
Heart Failure
Heart Block
Keywords: Bradyarrhythmia
Atrial Fibrillation
Ventricular Tachycardia
Ventricular Fibrillation
Heart Failure
Pacemaker
Implantable Cardioverter Defibrillator
Cardiac Resynchronization Therapy
Loop recorder
Registry
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2006-09-29
Enrollment: 8586
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving market released Medtronic Cardiac Rhythm device, worldwide

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.

Eligibility 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

Primary outcomes:
measure: To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices
timeFrame: 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Braine l'Alleud
country: Belgium
facility: C.H.I.R.E.C. - Site de Braine la Alleud
city: Brasschaat
country: Belgium
facility: A.Z. Klina
city: Mortsel
country: Belgium
facility: St. Vincentius-Campus St. Jozef
city: Namur
country: Belgium
facility: Centre de Medecine Cardiologique
city: Tournai
country: Belgium
facility: Centre Hosp. Régional du Tournaisis- Site Hopital
city: Tournai
country: Belgium
facility: Hôpital Notre Dame de Tournai
city: Beograd (Belgrade)
country: Former Serbia and Montenegro
facility: Cardiovascular Institute Dedinje
city: Nis
country: Former Serbia and Montenegro
facility: Clinical Centre Nis
city: Sremska Kamenica
country: Former Serbia and Montenegro
facility: Instit. of Cardiovasc. Diseases, Univ. of Novi Sad
city: Ahmedabad
country: India
facility: S.A.L. Hospital and Medical Institute
city: New Delhi
country: India
facility: Max Devki Devi Foundation
city: Safat
country: Kuwait
facility: Chest Disease Hospital
city: Ekaterinburg
country: Russian Federation
facility: Sverlovsk Regional Clinical Hospital N1
city: Khabarovsk
country: Russian Federation
facility: Regional Clinical Cardio Center
city: Moscow
country: Russian Federation
facility: FGU Moscow SRC of Pediatrics & Childrens Surgery
city: Moscow
country: Russian Federation
facility: Scientific Center of Heart Surgery by A.N. Bakulev
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Transplantology
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Regional Cardio Center
city: Novosibirsk
country: Russian Federation
facility: Scientific Research Institute of Circ. Pathology
city: Rostov-on-Don
country: Russian Federation
facility: Rostov area hospital
city: St. Petersburg
country: Russian Federation
facility: I.P. Pavlovs State Medical University- Hospital #2
city: St. Petersburg
country: Russian Federation
facility: Medical Academy of Postgraduate Studies
city: Tomsk
country: Russian Federation
facility: Scientific Research Insitute of Cardiology
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Center
city: Vladivostok
country: Russian Federation
facility: Regional Hospital #1
city: Volgograd
country: Russian Federation
facility: Volgograd cardio center
city: Jeddah
country: Saudi Arabia
facility: Sweidan Raed King Fahd Armed Forces Hospital
Study officials:
References: