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PANORAMA 2 Observational Study

Sponsor
Medtronic Bakken Research Center (Industry)
Overall Status
Completed
CT.gov ID
NCT01723566
Collaborator
(none)
4,706
Enrollment
1
Location
51.2
Actual Duration (Months)
91.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    4706 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry
    Actual Study Start Date :
    Jul 25, 2012
    Actual Primary Completion Date :
    Oct 31, 2016
    Actual Study Completion Date :
    Oct 31, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Describe region-specific clinical practice of CRDM device use [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • 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

    Exclusion criterion:

    • Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Hospital Cairo Egypt

    Sponsors and Collaborators

    • Medtronic Bakken Research Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medtronic Bakken Research Center
    ClinicalTrials.gov Identifier:
    NCT01723566
    Other Study ID Numbers:
    • PANORAMA 2
    First Posted:
    Nov 8, 2012
    Last Update Posted:
    Sep 1, 2017
    Last Verified:
    Aug 1, 2017
    Additional relevant MeSH terms:
    Arrhythmias, Cardiac

    Study Results

    No Results Posted as of Sep 1, 2017