Frailty Clinical Trial
— FFallSOfficial title:
Frailty and Falls Implantable System for Prediction and Prevention Investigational Study - FFallS Predictor
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Falls and Syncope Unit (FASU), Mercer's Institute for Successful Aging (MISA), St James's Hospital, Dublin 8 | Dublin | Leinster |
Lead Sponsor | Collaborator |
---|---|
University of Dublin, Trinity College | Medtronic Bakken Research Center, University of Copenhagen |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Established research of cardiac parameters of Reveal LINQ | building on established research of the cardiac parameters of the Reveal LINQ ™ to identify heart rate and rhythm disturbances in fallers and to evaluate their role in predicting a fall. | 16 months | |
Secondary | Development of Clinical risk stratification algorithm | Developing a clinical risk stratification algorithm for management, treatment and prevention of frailty and Falls. | 16 months |
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