Frailty and Falls Implantable System for Prediction and Prevention

NCT04881136 | Unknown

• 1 other identifier: TRI CRF 20-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Fall Patients; Frailty

Outcome Measures

Primary Outcomes (1)

• the number of falls associated with early changes in physiological parameters as recorded by the investigational Reveal LINQ™ Falls Prediction System.

  Uses the Reveal LINQ™ Falls Prediction Research System to identify early changes in physiological parameters which helps to create a profile on which to predict falls, with the potential to implement a score for the risk of falling based on monitoring of frailty parameters in the elderly measured with the implantable device.

  16 months

Secondary Outcomes (2)

• Established research of cardiac parameters of Reveal LINQ

  16 months

• Development of Clinical risk stratification algorithm

  16 months

Study Arms (1)

Reveal LINQ

EXPERIMENTAL

The Reveal LINQ™, which is a small implantable loop recorder that is used to monitor cardiac parameters at present is implanted to the participants who are have experienced non accidental falls. 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.

Device: Reveal LINQ™

Interventions

Reveal LINQ™ DEVICE

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.

Reveal LINQ

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to St James's due to a non-accidental fall (not a slip or trip), with a history of another non-accidental fall or syncope within the previous 3 years.
• Age ≥ 50 Years
• Participant is willing and has capacity to provide informed consent to the study

You may not qualify if:

• Inability or unwilling to follow or perform the study protocol requirements
• Cognitive impairment (MMSE \</= 20)
• Current Pacemaker or other implanted therapy devices.
• Known intolerance to subcutaneous implantable devices or any of the Reveal LINQ™ materials. 5. Life expectancy \< 12 months

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator
• University of Copenhagen: collaborator

Study Sites (1)

Falls and Syncope Unit (FASU), Mercer's Institute for Successful Aging (MISA), St James's Hospital, Dublin 8

Dublin, Leinster, 8, Ireland

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rose Anne Kenny, MD FRCP

  University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio R Perez, M Sc

CONTACT

014284182; PEREZSR@tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study will take place at St James's Hospital, in the Falls and Syncope Unit at MISA. Clinical data collection, processing, and data analysis will be conducted on-site by the study nurse and doctor and the on-site data manager recruited to the study team. The data collected by the investigational Falls Predictor software will be transmitted via CareLink™ and will be processed and analysed by Medtronic.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 11, 2021
• Study Start: March 23, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)