PANORAMA Observational Study

NCT ID: NCT00382525

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8586 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2013-03-31

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.

Conditions

Arrhythmia; Sinus Node Disease; Heart Failure; Heart Block

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Cardiac Rhythm Management device

Patients receiving a Medtronic Cardiac Rhythm Device, worldwide

Cardiac Rhythm Management device

Intervention Type: DEVICE

Interventions

Cardiac Rhythm Management device

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

S.A.L. Hospital and Medical Institute

Ahmedabad, , India

Max Devki Devi Foundation

New Delhi, , India

Chest Disease Hospital

Safat, , Kuwait

Regional Clinical Cardio Center

Khabarovsk, , Russia

FGU Moscow SRC of Pediatrics & Childrens Surgery

Moscow, , Russia

Scientific Center of Heart Surgery by A.N. Bakulev

Moscow, , Russia

Scientific Research Institute of Transplantology

Moscow, , Russia

Novosibirsk Regional Cardio Center

Novosibirsk, , Russia

Scientific Research Institute of Circ. Pathology

Novosibirsk, , Russia

Rostov area hospital

Rostov-on-Don, , Russia

I.P. Pavlovs State Medical University- Hospital #2

Saint Petersburg, , Russia

Medical Academy of Postgraduate Studies

Saint Petersburg, , Russia

Scientific Research Insitute of Cardiology

Tomsk, , Russia

Tyumen Cardiology Center

Tyumen, , Russia

Regional Hospital #1

Vladivostok, , Russia

Volgograd cardio center

Volgograd, , Russia

Sverlovsk Regional Clinical Hospital N1

Yekaterinburg, , Russia

Sweidan Raed King Fahd Armed Forces Hospital

Jeddah, , Saudi Arabia

Cardiovascular Institute Dedinje

Beograd (Belgrade), , Serbia and Montenegro

Clinical Centre Nis

Nis, , Serbia and Montenegro

Instit. of Cardiovasc. Diseases, Univ. of Novi Sad

Sremska Kamenica, , Serbia and Montenegro

Countries

Belgium; India; Kuwait; Russia; Saudi Arabia; Serbia and Montenegro

Other Identifiers

Version 1 April 25th, 2005

Identifier Type: -

Identifier Source: org_study_id