PANORAMA 2 Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Rhythm Disorders

• Study Type: Observational
• Enrollment (Actual): 4706

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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)

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2012-2019

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2012
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: November 6, 2012
• First Posted (Estimated): November 8, 2012

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: PANORAMA 2