PRoMOTE Follow-up Observational Study

NCT03009175 | Completed

• 1 other identifier: PRoMOTE FU
• Study Type: observational
• Target: 287
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker DEVICE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients under the age of 18 years.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 4, 2017
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 2, 2025

Record last verified: 2025-06