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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00382525
Other study ID # Version 1 April 25th, 2005
Secondary ID
Status Completed
Phase N/A
First received September 28, 2006
Last updated September 4, 2017
Start date January 2005
Est. completion date March 2013

Study information

Verified date September 2017
Source Medtronic Bakken Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 8586
Est. completion date March 2013
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Device:
Cardiac Rhythm Management device


Locations

Country Name City State
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 Centre Hosp. Régional du Tournaisis- Site Hopital Tournai
Belgium Hôpital Notre Dame de Tournai Tournai
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
India S.A.L. Hospital and Medical Institute Ahmedabad
India Max Devki Devi Foundation New Delhi
Kuwait Chest Disease Hospital Safat
Russian Federation 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 Novosibirsk Regional Cardio Center Novosibirsk
Russian Federation Scientific Research Institute of Circ. Pathology Novosibirsk
Russian Federation Rostov area hospital Rostov-on-Don
Russian Federation I.P. Pavlovs State Medical University- Hospital #2 St. Petersburg
Russian Federation Medical Academy of Postgraduate Studies 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
Saudi Arabia Sweidan Raed King Fahd Armed Forces Hospital Jeddah

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Belgium,  Former Serbia and Montenegro,  India,  Kuwait,  Russian Federation,  Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices 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.
2013
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