PANORAMA Observational Study

Heart Failure Clinical Trial

Official title:

Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382525
• Other study ID #: Version 1 April 25th, 2005
• 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
• 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

Related Conditions & MeSH terms

• Arrhythmia
• Heart Block
• Heart Failure
• Sick Sinus Syndrome
• Sinus Node Disease

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