Health Condition 1: null- Patients with arrthymias and eligible for an implant of any CRDM therapy
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
India Medtronic Pvt Ltd