Status:
UNKNOWN
Frailty and Falls Implantable System for Prediction and Prevention
Lead Sponsor:
University of Dublin, Trinity College
Collaborating Sponsors:
Medtronic Cardiac Rhythm and Heart Failure
University of Copenhagen
Conditions:
Fall Patients
Frailty
Eligibility:
All Genders
50+ years
Phase:
NA
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™)...
Detailed Description
Falls are an evolving frailty state and are the most common reason for older adults to attend the Emergency Room (ER) and for admission to long term institutional care. The Irish Longitudinal Study on...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04881136
Start Date
March 23 2021
End Date
June 30 2022
Last Update
June 28 2021
Active Locations (1)
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1
Falls and Syncope Unit (FASU), Mercer's Institute for Successful Aging (MISA), St James's Hospital, Dublin 8
Dublin, Leinster, Ireland, 8