PRoMOTE Follow-up Observational Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03009175

Acronym

PRoMOTE FU

Enrollment

287

Registered

2017-01-04

Start date

2013-06-30

Completion date

2014-08-31

Last updated

2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Interventions

DEVICEImplantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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.

Design outcomes

Primary

Measure	Time frame
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.	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026