PANORAMA 2 Observational Study

Heart Rhythm Disorders Clinical Trial

Official title:

Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01723566
• Other study ID #: PANORAMA 2
• Status: Completed
• Phase: N/A
• First received: November 6, 2012
• Last updated: August 31, 2017
• Start date: July 25, 2012
• Est. completion date: October 31, 2016

Study information

• Verified date: August 2017
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4706
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Rhythm Disorders

Locations

Country	Name	City	State
Egypt	Cairo University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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