PANORAMA 2 Observational Study

NCT01723566 | Completed

• 1 other identifier: PANORAMA 2
• Study Type: observational
• Target: 4,706
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Rhythm Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Cairo University Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: November 8, 2012
• Study Start: July 25, 2012
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: July 3, 2025

Record last verified: 2017-08

Locations

EG (1)