PRoMOTE Follow-up Observational Study

Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)

The purpose of the study is:

• To evaluate the Heart Failure Risk Status (HFRS) feature performance.
• To establish the feasibility of remote follow-up in which patient risk triaging is performed by nurse-led review of HFRS feature as supplemental information.

Inclusion Criteria:

Patients that meet all of following criteria could be included in the study:

• Implant of a commercially available Medtronic CRTD or ICD device with or without the Optivol Fluid Status Monitoring feature.
• Inclusion in the Medtronic Carelink Network.
• Local consent available for CL network as well as general local consent available for the use of data in observational studies signed and informative sheet delivered.

Exclusion Criteria:

• Patients under the age of 18 years.