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Panorama 2 is a multi-national, multi-center, prospective, non-randomized, post-market, observational registry conducted in various regions across the world

PANORAMA 2, Medtronic CRDM Implantable Cardiac Device Long Term Registry - Panorama 2

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/03/003464
Enrollment
8500
Registered
2013-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with arrthymias and eligible for an implant of any CRDM therapy

Interventions

Intervention1: Not applicable: Not applicable Intervention2: There is no intervention in this study.: Patients receiving therapy from an eligible product, i.e all commercially available implantable Me

Sponsors

India Medtronic Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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 criteria

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

Design outcomes

Primary

MeasureTime frame
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 devicesTimepoint: Minimum 1 year post implant and maximum 5 years post implant

Secondary

MeasureTime frame
To collect region-specific data on product reliability (Serious Adverse Device Effects, device related deaths and device related cardiovascular hospitalizations) of implantable Medtronic CRDM devicesTimepoint: Minimum 1 year post implant and maximum 5 years post implant

Countries

Bangladesh, Brazil, India, South Africa

Contacts

Public ContactRajesh Radhakrishnan

India Medtronic Pvt Ltd

rajesh.radhakrishnan@medtronic.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026