PRoMOTE Follow-up Observational Study

Medtronic Cardiac Rhythm and Heart Failure287 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

287

Conditions

Heart Failure

Interventions

Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/PacemakerDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.

Time frame: 6 months

Data from ClinicalTrials.gov

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