Cardiac ArrythmiasFRAILTY-CW2NCT06930833
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
An observational study of Cardiac Arrythmias and Valve Heart Disease, run by Corsano Health B.V. at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- What is being tested?
- Corsano CardioWatch 287-2
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- ≥ 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Reinier de Graaf Gasthuis
Delft, South Holland, 2625AD
Eelko Ronner, MD, PhD, 015 - 260 33 20 ext. +31, eronner@rdgg.nl
Mariska van Vliet, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Being tested
- Corsano CardioWatch 287-2
- Keywords
- Frailty, 6-minute walking test, G8-score, wristband, wearable, remote monitoring, cardiac surgical interventions
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corsano CardioWatch 287-2Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Corsano CardioWatch 287-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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)
Measured: 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.
- 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)
Measured: 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
Participants will be categorized based on the 6MWT. If the 6MWT is less than 300 meters, the participant is categorized as low endurance (LE). If the 6MWT is greater than 300 meters, the participant is classified as normal endurance (NE). The 300 meter cut off point ismchosen because it is widely used in literature.
The following parameters will be calculated for every participant separately and will thereafter be averaged over all patients:.
- Accuracy: (TP + TN) / (TP + TN + FP + FN)
- Specificity: TN / (TN + FP)
- Sensitivity: TP / (TP + FN)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startMay 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsano Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariska van Vliet, MD, PhD, Principal investigator, Reinier de Graaf Groep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930833
- Sponsor's protocol ID
- FRAILTY
- Acronym
- FRAILTY-CW2
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
- ClinicalTrials.gov ID
- NCT06930833
- Acronym / sponsor ID
- FRAILTY-CW2 / FRAILTY
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Keywords
- Frailty, 6-minute walking test, G8-score, wristband, wearable, remote monitoring, cardiac surgical interventions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Corsano Health B.V.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiac surgical intervention | – | Device: Corsano CardioWatch 287-2Patients ≥ 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (7 listed)
- ≥ 70 years old
- Be able to provide consent
- Be scheduled to undergo one of the following procedures:
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corsano CardioWatch 287-2Eligible 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. | Device | Patients undergoing cardiac surgical intervention |
Primary outcome
Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2
Time frame: 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)
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)
Frailty score agreement between FRAIL questionnaire and CardioWatch 287-2
Time frame: 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)
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)
1 secondary outcome
Frailty score agreement between 6-minute walking test and CardioWatch 287-2
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariska van Vliet, MD, PhD principal investigator
Reinier de Graaf Groep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrythmias and Valve Heart Disease, run by Corsano Health B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eelko Ronner, MD, PhD (015-2603320 ext. +31, eronner@rdgg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2 (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.