PANORAMA Observational Study

Completed

• Conditions: Heart Failure; Sinus Node Disease; Arrhythmia; Heart Block

• Registration Number: NCT00382525
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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.

Study Timeline

• Study Start: 2005-01-01
• Study First Submitted: 2006-09-28
• Study First Submitted QC: 2006-09-28
• Study First Posted: 2006-09-29
• Primary Completion: 2012-10
• Study Completion: 2013-03-01
• Status Verified: 2017-09
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8586

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (27)

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, Belgium

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, Former Serbia and Montenegro

S.A.L. Hospital and Medical Institute; 🇮🇳 Ahmedabad, India

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