Heart Rhythm DisordersNCT01723566
PANORAMA 2 Observational Study
An observational study of Heart Rhythm Disorders, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Egypt.
Trial summary
Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Rhythm Disorders
- How many people
- 4,706 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2012to 31 Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that have a Medtronic implantable CRDM Device implanted (including Vitatron), which is commercially available at the start of the registry or becomes commercially available during the course of the registry, and used within its intended use, may be included. These products are: * Pacemaker systems: Implantable Pulse Generators (IPG) and cardiac leads * Defibrillation systems: Implantable Cardioverter Defibrillators (ICD) and cardiac leads * Resynchronization systems: Cardiac Resynchronization Therapy (CRT): * Cardiac Resynchronization Therapy - Pacemaker (CRT-P) and cardiac leads * Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and cardiac leads * Implantable Loop Recorders (ILR)
Who may be able to join
- Patient is 18 years of age or older (lower age limit dependent on local law: to be specified in country-specific addendum to the clinical investigational plan, if applicable)
- Patient or Legally Authorized Representative provides signed and dated authorization and/or consent per institution and local requirements
- Patient will be treated with a commercially available implantable Medtronic CRDM device/ Vitatron device within maximally 30 days after enrollment or within 3 days prior to enrollment
Who cannot join
- Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry
Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability.
The Panorama 2 registry will enable Medtronic to increase data collection of clinical practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in various regions across the world and on product reliability of its CRDM devices.
- Conditions
- Heart Rhythm Disorders
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe region-specific clinical practice of CRDM device use
To describe the region-specific current clinical practices associated with the device treatment of patients receiving implantable Medtronic CRDM devices by collecting information on the patient characteristics (demographics, medical history and cardiovascular status), the type of Medtronic CRDM devices used, the indication for the use of the Medtronic CRDM devices and the clinical outcomes of the treatment with the Medtronic CRDM devices (all deaths, cardiovascular hospitalizations, Serious Adverse Device Effects and NYHA class).
Measured: 2012-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study start25 Jul 2012
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rhythm DisordersStudies 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
- 4,706 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
- NCT01723566
- Sponsor's protocol ID
- PANORAMA 2
- Status last verified
- Aug 2017
- First submitted
- 6 Nov 2012
- 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
- Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry
- ClinicalTrials.gov ID
- NCT01723566
- Acronym / sponsor ID
- PANORAMA 2
- Conditions
- Heart Rhythm Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,706 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2012 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 8 Nov 2012 (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.
Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in real world patient population is essential for Medtronic to be able to effectively develop new products and adjust existing products. In addition Medtronic is committed to monitor the safety of its products throughout the entire life cycle to ensure maximum product reliability.
The Panorama 2 registry will enable Medtronic to increase data collection of clinical practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in various regions across the world and on product reliability of its CRDM devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that have a Medtronic implantable CRDM Device implanted (including Vitatron), which is commercially available at the start of the registry or becomes commercially available during the course of the registry, and used within its intended use, may be included. These products are: * Pacemaker systems: Implantable Pulse Generators (IPG) and cardiac leads * Defibrillation systems: Implantable Cardioverter Defibrillators (ICD) and cardiac leads * Resynchronization systems: Cardiac Resynchronization Therapy (CRT): * Cardiac Resynchronization Therapy - Pacemaker (CRT-P) and cardiac leads * Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and cardiac leads * Implantable Loop Recorders (ILR)
Key inclusion criteria (3 listed)
- Patient is 18 years of age or older (lower age limit dependent on local law: to be specified in country-specific addendum to the clinical investigational plan, if applicable)
- Patient or Legally Authorized Representative provides signed and dated authorization and/or consent per institution and local requirements
- Patient will be treated with a commercially available implantable Medtronic CRDM device/ Vitatron device within maximally 30 days after enrollment or within 3 days prior to enrollment
Key exclusion criteria (1 listed)
- Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe region-specific clinical practice of CRDM device use
Time frame: 2012-2019
To describe the region-specific current clinical practices associated with the device treatment of patients receiving implantable Medtronic CRDM devices by collecting information on the patient characteristics (demographics, medical history and cardiovascular status), the type of Medtronic CRDM devices used, the indication for the use of the Medtronic CRDM devices and the clinical outcomes of the treatment with the Medtronic CRDM devices (all deaths, cardiovascular hospitalizations, Serious Adverse Device Effects and NYHA class).
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Rhythm Disorders, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Egypt.
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 3 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 1 site in Egypt. 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?
Describe region-specific clinical practice of CRDM device use (time frame: 2012-2019). 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.