FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorCorsano Health B.V.

About this trial

The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation.

The study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm.

The main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.

Eligibility criteria

Qualifiers

≥ 70 years old

Be able to provide consent

Aortic valve replacement

Mitral valve repair with MitraClip

Disqualifiers

Unable to wear the Corsano CardioWatch 287-2 due to reasons such as allergic reactions, wounds, amputations etc.;

Unable or unwilling to sign informed consent;

Significant mental or cognitive impairment;

Cardiovascular disease where heart rate is not measurable (e.g. LVAD)

Trial design

Treatments tested in this trial

  • Corsano CardioWatch 287-2

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators