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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57331
Enrollment
40
Registered
2024-03-23
Start date
2026-02-11
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Interventions

The CardioWatch 287-2 is a wireless remote monitoring device intended for continuous collection of physiological data in home and healthcare settings. This includes heart rate, heart rate variability
via a mobile phone application or gateway to a server or health cloud where it is stored and&nbsp
made available for further analysis.

Sponsors

Corsano Health B.V.
Lead Sponsor

Eligibility

Age
65 Years to 99 Years

Inclusion criteria

Inclusion criteria: * >= 70 years old * Able to provide consent * Be scheduled to undergo on of the following procedures: ** Aortic valve replacement ** Mitral valve repair with MitraClip ** Implantation of a pacemaker ** Percutaneous coronary intervention (PCI)

Exclusion criteria

Exclusion criteria: * 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)

Design outcomes

Primary

MeasureTime frame
Frailty algorithm of Corsano Cardiowatch epoch agreement with corresponding G8 measured in overall accuracy and weighted kappa between Frailty algorithm of Corsano Cardiowatch and the golden standard G8 questionnaire (frail or non-frail) and the FRAIL score (frail, pre-frail and non-frail).

Secondary

MeasureTime frame
Frailty algorithm of Corsano Cardiowatch epoch agreement with 6MWT measured in overall accuracy, sensitivity and specificity.

Countries

Netherlands

Contacts

Public ContactN Jaspers

Corsano Health B.V.

info@corsano.com+31 61 640 7778

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026