PRoMOTE Follow-up Observational Study (PRoMOTE FU)

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker

Study type: Observational

Funder types: Industry

Identifiers

NCT03009175

PRoMOTE FU

Details and patient eligibility

About

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.

Enrollment: 287 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.