PRoMOTE Follow-up Observational Study (PRoMOTE FU)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker

• Study Type: Observational
• Enrollment (Actual): 287

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Study population will include patients of both sexes included in the Medtronic CareLink® Network and implanted with a Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities device (CRT-D) at Hospital Araba (former Hospital Txagorritxu). There are approximately 223 ICD and CRT-D patients included in the CareLink® Network at this site, and average number of transmissions per month is ~80, so it is expected that 480 transmissions are received during the study duration.

From this population, less than 10% are implanted with a device without Optivol® feature. For these patients we will not have HFRS data.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: December 30, 2016
• First Posted (Estimated): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: PRoMOTE FU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED