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

NCT06930833 | Not Yet Recruiting

• 1 other identifier: FRAILTY
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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, 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

Keywords

Frailty; 6-minute walking test; G8-score; wristband; wearable; remote monitoring; cardiac surgical interventions

Outcome Measures

Primary Outcomes (2)

• Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2

  G8 questionnaire: when a G8 score ≤ 14 is obtained the patient is considered as frail. When a G8 score \> 14 is obtained the patient is considered as non-frail The following parameters will be calculated: * Accuracy: the proportion of correctly classified frailty stages compared to the total number of frailty stages. This accuracy will be calculated for every participant separately and will thereafter be averaged over all patients. o Accuracy: (TP + TN) / (TP + TN + FP + FN) * For comparing the G8 score outcomes and the CardioWatch frailty scores the (frail vs. non-frail) the following parameters will be calculated: * Specificity: TN / (TN + FP) * Sensitivity: TP / (TP + FN)

  From start to end of first CardioWatch 287-2 measurement (~2 week prior to surgery) and from start to end of second CardioWatch 287-2 measurement ('~2 months after surgery)

• Frailty score agreement between FRAIL questionnaire and CardioWatch 287-2

  FRAIL score: when a FRAIL score ≥ 3 is obtained the patient is considered as frail. When a FRAIL score of 1-2 is obtained the patient is considered as pre-frail, and when a FRAIL score of 0 is obtained the patient is considered as non-frail. The following parameters will be calculated: * Accuracy: the proportion of correctly classified frailty stages compared to the total number of frailty stages. This accuracy will be calculated for every participant separately and will thereafter be averaged over all patients. o Accuracy: (TP + TN) / (TP + TN + FP + FN) * For comparing the FRAIL score outcomes and the CardioWatch frailty scores (frail, pre-frail and non-frail) the following parameters will be calculated for every outcome possibility (CardioWatch: frail; pre-frail; non-frail) and participant separately and will thereafter be averaged per outcome possibility over all patients: * Specificity: TN / (TN + FP) * Sensitivity: TP / (TP + FN)

  From start to end of first CardioWatch 287-2 measurement (~2 week prior to surgery) and from start to end of second CardioWatch 287-2 measurement ('~2 months after surgery)

Secondary Outcomes (1)

• Frailty score agreement between 6-minute walking test and CardioWatch 287-2

  From start to end of first CardioWatch 287-2 measurement (~2 week prior to surgery) and from start to end of second CardioWatch 287-2 measurement ('~2 months after surgery)

Study Arms (1)

Patients undergoing cardiac surgical intervention

Patients ≥ 70 years of age who are scheduled to undergo aortic valve replacement, mitral valve repair with MitraClip, implantation of a pacemaker or percutaneous coronary intervention (PCI) at the Reinier de Graaf Gasthuis Cardiology department.

Device: Corsano CardioWatch 287-2

Interventions

Corsano CardioWatch 287-2 DEVICE

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.

Patients undergoing cardiac surgical intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 70 years of age who are scheduled to undergo aortic valve replacement, mitral valve repair with MitraClip, implantation of a pacemaker or percutaneous coronary intervention (PCI) at the Reinier de Graaf Gasthuis Cardiology department.

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Sites (1)

Reinier de Graaf Gasthuis

Delft, South Holland, 2625AD, Netherlands

Location

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariska van Vliet, MD, PhD

  Reinier de Graaf Groep

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eelko Ronner, MD, PhD

CONTACT

015-2603320; eronner@rdgg.nl

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)