ArrhythmiaNCT00382525
PANORAMA Observational Study
An observational study of Arrhythmia and Sinus Node Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 27 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmia, Sinus Node Disease, Heart Failure
- What is being tested?
- Cardiac Rhythm Management device
- Type of treatment
- Medical device
- How many people
- 8,586 participants
- Where
- 27 sitesin 6 countries
- Study dates
- Jan 2005to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving market released Medtronic Cardiac Rhythm device, worldwide
Who may be able to join
- (To be) implanted with a Medtronic market-released cardiac device,
- Signed Patient Data Release Form.
Who cannot join
- Unwillingness or inability to cooperate or give voluntary consent
Trial locations and contacts
27 sites in 6 countries.
27 sites in 6 countries
Russia14 sites
Regional Clinical Cardio Center
Khabarovsk
FGU Moscow SRC of Pediatrics & Childrens Surgery
Moscow
Scientific Center of Heart Surgery by A.N. Bakulev
Moscow
Scientific Research Institute of Transplantology
Moscow
Novosibirsk Regional Cardio Center
Novosibirsk
Scientific Research Institute of Circ. Pathology
Novosibirsk
Rostov area hospital
Rostov-on-Don
I.P. Pavlovs State Medical University- Hospital #2
Saint Petersburg
Medical Academy of Postgraduate Studies
Saint Petersburg
Scientific Research Insitute of Cardiology
Tomsk
Tyumen Cardiology Center
Tyumen
Regional Hospital #1
Vladivostok
Volgograd cardio center
Volgograd
Sverlovsk Regional Clinical Hospital N1
Yekaterinburg
Belgium6 sites
C.H.I.R.E.C. - Site de Braine la Alleud
Braine-l'Alleud
A.Z. Klina
Brasschaat
St. Vincentius-Campus St. Jozef
Mortsel
Centre de Medecine Cardiologique
Namur
Centre Hosp. Régional du Tournaisis- Site Hopital
Tournai
Hôpital Notre Dame de Tournai
Tournai
Serbia and Montenegro3 sites
Cardiovascular Institute Dedinje
Beograd (Belgrade)
Clinical Centre Nis
Nis
Instit. of Cardiovasc. Diseases, Univ. of Novi Sad
Sremska Kamenica
India2 sites
S.A.L. Hospital and Medical Institute
Ahmedabad
Max Devki Devi Foundation
New Delhi
About this study
Official title: 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.
Read the 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
- Being tested
- Cardiac Rhythm Management device
- Keywords
- Bradyarrhythmia, Atrial Fibrillation, Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, Loop recorder, Registry
- Medical subject headings
- Arrhythmias, Cardiac, Sick Sinus Syndrome, Heart Failure, Heart Block, Bradycardia, Atrial Fibrillation, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rhythm Management deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cardiac Rhythm Management device | Patients receiving a Medtronic Cardiac Rhythm Device, worldwide Receives: Device: Cardiac Rhythm Management device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startJan 2005
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382525
- Sponsor's protocol ID
- Version 1 April 25th, 2005
- Status last verified
- Sep 2017
- First submitted
- 28 Sep 2006
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Long Term Observational Study of Patients Implanted With Medtronic CRDM Implantable Cardiac Devices
- ClinicalTrials.gov ID
- NCT00382525
- Acronym / sponsor ID
- Version 1 April 25th, 2005
- Conditions
- Arrhythmia, Sinus Node Disease, Heart Failure, Heart Block
- Keywords
- Bradyarrhythmia, Atrial Fibrillation, Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure, Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,586 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cardiac Rhythm Management device | – | Device: Cardiac Rhythm Management devicePatients receiving a Medtronic Cardiac Rhythm Device, worldwide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving market released Medtronic Cardiac Rhythm device, worldwide
Key inclusion criteria (2 listed)
- (To be) implanted with a Medtronic market-released cardiac device,
- Signed Patient Data Release Form.
Key exclusion criteria (1 listed)
- Unwillingness or inability to cooperate or give voluntary consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rhythm Management device | Device | Patients with Cardiac Rhythm Management device |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmia and Sinus Node Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 27 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Russia, Belgium, Serbia and Montenegro, India, Kuwait and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To construct a computerized database of national profiles and epidemiological data on patients wearing Medtronic Cardiac Rhythm Management Devices (time frame: 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.