Clinical trial NCT06930833: FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
Official title: FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrythmias
Valve Heart Disease
Cardiac Ischemia
Keywords: Frailty
6-minute walking test
G8-score
wristband
wearable
remote monitoring
cardiac surgical interventions
Lead sponsor: Corsano Health B.V.
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.

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 data is required to develop, train and validate an algorithm to classify frailty for the Corsano CardioWatch 287-2. The FRAILTY-CARDIOWATCH study consists of two phases, of which only phase 1 (data collection and algorithm development and training) will be addressed in this protocol.

Primary Objective:

The main objective is to determine the agreement of the frailty classification between the Corsano CardioWatch and the gold standard Geriatric 8 (G8) questionnaire as well as the FRAIL scale.

Secondary objectives:

The secondary objective is to determine the agreement of the frailty classification between the Corsano CardioWatch and the 6-minute walk test (6MWT).

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.

Study design:

Patients are asked to undergo a G8 assessment, FRAIL scale assessment, 6MWT and 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. Collected data of 20 patients will be used to develop and train a frailty classification algorithm for the Corsano CardioWatch 287-2 (phase I).

Main study parameters/endpoints:

Accuracy of the frailty classifications between the G8 assessment or FRAIL scale and the frailty algorithm of Corsano CardioWatch 287-2.

Eligibility criteria: Inclusion Criteria:

* ≥ 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 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)

Primary outcomes:
measure: Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2
timeFrame: 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)
measure: Frailty score agreement between FRAIL questionnaire and CardioWatch 287-2
timeFrame: 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:
measure: Frailty score agreement between 6-minute walking test and CardioWatch 287-2
timeFrame: 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)
Other outcomes:
Locations:
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid Holland
Study officials:
affiliation: Reinier de Graaf Groep
name: Mariska van Vliet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: