PANORAMA Observational Study

September 4, 2017 updated by: Medtronic Bakken Research Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

8586

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Braine l'Alleud, Belgium
        • C.H.I.R.E.C. - Site de Braine la Alleud
      • Brasschaat, Belgium
        • A.Z. Klina
      • Mortsel, Belgium
        • St. Vincentius-Campus St. Jozef
      • Namur, Belgium
        • Centre de Medecine Cardiologique
      • Tournai, Belgium
        • Centre Hosp. Régional du Tournaisis- Site Hopital
      • Tournai, Belgium
        • Hôpital Notre Dame de Tournai
  • Former Serbia and Montenegro
      • Beograd (Belgrade), Former Serbia and Montenegro
        • Cardiovascular Institute Dedinje
      • Nis, Former Serbia and Montenegro
        • Clinical Centre Nis
      • Sremska Kamenica, Former Serbia and Montenegro
        • Instit. of Cardiovasc. Diseases, Univ. of Novi Sad
  • India
      • Ahmedabad, India
        • S.A.L. Hospital and Medical Institute
      • New Delhi, India
        • Max Devki Devi Foundation
  • Kuwait
      • Safat, Kuwait
        • Chest Disease Hospital
  • Russian Federation
      • Ekaterinburg, Russian Federation
        • Sverlovsk Regional Clinical Hospital N1
      • Khabarovsk, Russian Federation
        • Regional Clinical Cardio Center
      • Moscow, 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
      • Novosibirsk, Russian Federation
        • Novosibirsk Regional Cardio Center
      • Novosibirsk, Russian Federation
        • Scientific Research Institute of Circ. Pathology
      • Rostov-on-Don, Russian Federation
        • Rostov area hospital
      • St. Petersburg, Russian Federation
        • I.P. Pavlovs State Medical University- Hospital #2
      • St. Petersburg, Russian Federation
        • Medical Academy of Postgraduate Studies
      • Tomsk, Russian Federation
        • Scientific Research Insitute of Cardiology
      • Tyumen, Russian Federation
        • Tyumen Cardiology Center
      • Vladivostok, Russian Federation
        • Regional Hospital #1
      • Volgograd, Russian Federation
        • Volgograd cardio center
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Sweidan Raed King Fahd Armed Forces Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving market released Medtronic Cardiac Rhythm device, worldwide

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Cardiac Rhythm Management device
Patients receiving a Medtronic Cardiac Rhythm Device, worldwide
Device: Cardiac Rhythm Management device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices
Time Frame: 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.
2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 28, 2006

First Submitted That Met QC Criteria

September 28, 2006

First Posted (Estimate)

September 29, 2006

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1 April 25th, 2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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