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

NCT06930833 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-04-20

No results posted yet for this study

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, 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.

Conditions

  • Cardiac Arrythmias
  • Valve Heart Disease
  • Cardiac Ischemia

Interventions

DEVICE

Corsano CardioWatch 287-2

Eligible patients are asked to wear the Corsano CardioWatch 287-2 for 6 days, of which 3 days approximately 2 weeks before the procedure and 3 days approximately 2 months after the procedure.

Sponsors & Collaborators

  • Corsano Health B.V.

    lead INDUSTRY

Principal Investigators

  • Mariska van Vliet, MD, PhD · Reinier de Graaf Groep

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930833 on ClinicalTrials.gov