Panorama 2 is a multi-national, multi-center, prospective, non-randomized, post-market, observational registry conducted in various regions across the world
Phase 4
- Conditions
- Health Condition 1: null- Patients with arrthymias and eligible for an implant of any CRDM therapy
- Registration Number
- CTRI/2013/03/003464
- Lead Sponsor
- India Medtronic Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 8500
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
•Patient has exclusion criteria per local law (to be specified in country-specific addendum to the clinical investigational plan, if applicable)
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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