Status:
NOT_YET_RECRUITING
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
Lead Sponsor:
Corsano Health B.V.
Conditions:
Cardiac Arrythmias
Valve Heart Disease
Eligibility:
All Genders
70+ years
Brief Summary
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,...
Detailed Description
Rationale: Wrist wearables have the potential to continuously and accurately classify frailty. The Corsano CardioWatch 287-2 is such a medical device with that potential. The collection of clinical d...
Eligibility Criteria
Inclusion
- ≥ 70 years old
- Be able to provide consent
- Be scheduled to undergo one of the following procedures:
- Aortic valve replacement
- Mitral valve repair with MitraClip
- Implantation of a pacemaker
- Percutaneous coronary intervention (PCI)
Exclusion
- 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)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06930833
Start Date
May 1 2025
End Date
October 1 2026
Last Update
April 20 2025
Active Locations (1)
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1
Reinier de Graaf Gasthuis
Delft, South Holland, Netherlands, 2625AD