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Frailty and Falls Implantable System for Prediction and Prevention

NCT04881136 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-06-28

No results posted yet for this study

Summary

The Falls Predictor Clinical Investigation is a research study that aims to investigate the value of an update (Falls Prediction RAMware) to an implantable cardiac monitoring device (The Reveal LINQ™) in predicting unexplained falls. The Reveal LINQ™ is an implantable cardiac monitoring system manufactured by Medtronic that has the ability to monitor heart rate, rhythm and activity and is preprogrammed to detect abnormalities. An R\&D team at Medtronic has been collaborating with the study PI Prof Rose Anne Kenny on this project they are responsible for developing a software update for the Reveal LINQ™ that would enable the device to collect additional sensor data such as accelerometer (step count) and Posture change. The additional investigational fields along with the standard cardiac fields that are monitored may be useful in predicting or identifying physiological changes before a fall. The study will involve up to 30 patients, recruited and consented from recurrent non-accidental fallers referred to the Falls and Syncope Unit at St James's Hospital, Dublin.

Conditions

Interventions

DEVICE

Reveal LINQ™

The physical device is the Reveal LINQ™, which is a small implantable loop recorder that is used to monitor cardiac parameters at present. The Investigational Falls Prediction RAMware is software that will be downloaded on to the Reveal LINQ™ that will enable it to collect additional sensor information including accelerometer and posture count data that will be used for gait analysis.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    collaborator INDUSTRY

  • University of Copenhagen

    collaborator OTHER

  • University of Dublin, Trinity College

    lead OTHER

Principal Investigators

  • Rose Anne Kenny, MD FRCP · University of Dublin, Trinity College

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04881136 on ClinicalTrials.gov