Wearable DeviceNCT07322510
HEARTS in Sync + CardioWatch 287-2
A study testing Remote Patient Monitoring with Corsano CardioWatch 287-2 in people with Wearable Device and Cardiovascular Disease, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wearable Device, Cardiovascular Disease, ASCVD Management
- What is being tested?
- Remote Patient Monitoring with Corsano CardioWatch 287-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2026to Feb 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet CR inclusion criteria requirements and who are enrolling in virtual cardiac rehab program, HEARTS in Sync, in Nova Scotia.
Who cannot join
- Phones that are not compatible with the Corsano system.
- Huawei P8 Lite
- Huawei P9 Lite
- Xiaomi Mi 6
- Huawei P20 Lite
- Apple iOS version lower than 14.5
- Android OS version lower than 8.0
- Android or Apple devices without Bluetooth® 5.0 Low Energy capability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Mumford Professional Centre
Halifax, Nova Scotia, B3L4P1
Wanda Firth, 9024733846, wanda.firth@nshealth.ca
About this study
Official title: Health Behaviour Change, Education on Risk Factor Reduction, Physical Activity Guidance, and Nutrition Counselling With a Remote Team to Support Patient Progress Using Technology in Synchronization With Medication Management and CardioWatch 287-2. (HEARTS in Sync + CardioWatch 287-2)
The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. The question guiding this study is: Do patient clinical outcomes differ between those who use the CardioWatch 287-2 during the HEARTS in Sync program as compared to those who participate without using the CardioWatch 287-2? The comparison will happen between two non-randomized groups of patients who are enrolled in the HEARTS in Sync virtual CR program.
The wearable device (CardioWatch 287-2), worn on patient's wrists, will provide clinicians with physiological information to better mirror the clinical oversight provided to an in-person CR program. Participants who choose to use the device will be asked to wear it daily. The clinical team will review weekly summary reports to help guide participant progress through the 13-week program.
Read more
The primary objectives of this study are to:
- Characterize participants (e.g., demographic health history, patient feedback) between those who choose to use the CardioWatch 287-2 device and those who do not.
- Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by:
- Tracking patient enrollment, attendance in virtual education sessions, and program completion rates,
- Evaluating change in patient bloodwork outcomes,
- Measuring change is physical ability,
- Analyzing changes in eating behaviours, and
- Examining quality of life using validated tools.
- Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by:
- Assessing device adherence
- Reviewing patient feedback survey, and
- Determining if clinician team were able to access and interpret data collected throughout the program
The secondary objective of this study is to compare clinical outcomes of device users during the HEARTS in Sync program with patients who completed the on-site CR program.
This research aims to better understand how a medical-grade device may improve virtual CR programming to extend clinical care to the community. As a result, this could lead to a more personalized care and better results for patients.
- Being tested
- Remote Patient Monitoring with Corsano CardioWatch 287-2
- Keywords
- virtual cardiac rehabilitation, wearable device, remote monitoring
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Patient Monitoring with Corsano CardioWatch 287-2Device
Participants wear a CardioWatch 287-2 during the 13-week virtual cardiac rehabilitation program, HEARTS in Sync. The program is delivered by the Nova Scotia Health clinical team that consists of a Registered Nurse, Registered Dietitian and Physiotherapist.
The CardioWatch 287-2 collects health information such as pulse rate, blood pressure, sleep, steps, activity, and more. This information is available for participants to check on the patient app called "Corsano". The information is also summarized on a weekly report that reports 7-day average which the clinical team will review on the Healthcare Practitioner web-based portal. This information is used to guide the participants rehabilitation journey.
These participants will be followed to understand program adherence, patient-reported usability and acceptability, and clinical outcomes collected at baseline and program discharge.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Cardiac Rehab + Corsano CardioWatch 287-2 | Experimental | Not described Receives: Device: Remote Patient Monitoring with Corsano CardioWatch 287-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Program Adherence
The proportion (%) of program sessions attended by each patient, comparing device users and non-device user. Attendance percentage will be obtained by program records.
Measured: From enrollment to 13-week program completion
Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and Non-Device Users
Change in Metabolic Equivalents measured during the baseline exercise stress test and discharge stress test.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Fat Intake Score Between Device Users and Non-Device Users
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Fibre Intake Score Between Device Users and Non-Device Users
Change in patient fibre intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Sodium Intake Score Between Device Users and Non-Device Users
Change in patient sodium intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Sugar Intake Score Between Device Users and Non-Device Users
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Quality of Life Ladder Score Between Device Users and Non-Device Users
Examine change in patient-reported quality of life using the Quality of Life Ladder at initial/baseline and discharge report.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Satisfaction with Life Between Device Users and Non-Device Users
Examine change in patient-reported quality of life using the Satisfaction with Life Scale at initial/baseline and discharge report.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Characterize Participants
Determine demographic and health history between device users and non-device users
Measured: Initial (at assessment)
Device Adherence to Wearing the CardioWatch 287-2
Device adherence will be assessed by calculating the proportion of total study days during which each participant wore the device for the required monitoring duration. Adherence will be categorized into one of the three following groups:
- High compliance: ≥ 50% daily wear time (~12 hours/day on all 7 days/week)
- Moderate compliance: ≥ 25% daily wear time (~6 hours/day)
- Low compliance: ≥ 12.5% daily wear time (~3 hours/day)
The unit of measure is percentage (%) of days with required wear time and proportion (%) of participants in each adherence category.
Device adherence is automatically captured through the Corsano CardioWatch 287-2 system.
Measured: From enrollment to the end of the program at 13-weeks
Patient-Reported Usability and Acceptability of the CardioWatch 287-2
Participants' perceptions of usability, comfort, and acceptability of the device will be assessed using a study-specific questionnaire that includes both participant rating scale and free-text responses. Only the ranked items will be used for quantitative outcome reporting while the free-text responses will be summarized descriptively.
Measured: After completion of the program (e.g. after 13 weeks)
Clinician-Reported Usability of the CardioWatch 287-2 System
Clinicians' assessment of device usability including ease of data interpretation, integration into clinical workflow, and perceived clinical value. This will be a descriptive analysis only captured through a study-specific focus group.
Measured: Up to 1 year after study completion
Change in Triglyceride Level Change Between Device Users and Non-Device Users
Triglycerides (mmol/L) will be measured via standard blood panel.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Total Cholesterol Level Change Between Device Users and Non-Device Users
Total cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in HDL Cholesterol Level Change Between Device Users and Non-Device Users
HDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in LDL Cholesterol Level Change Between Device Users and Non-Device Users
LDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Hemoglobin A1C Level Change Between Device Users and Non-Device Users
HbA1C (%) will be measured via standard bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Systolic Blood Pressure Between Device Users and Non-Device Users
Systolic blood pressure (mmHg) measured by a blood pressure monitor.
Measured: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Diastolic Blood Pressure Between Device Users and Non-Device Users
Diastolic blood pressure (mmHg) measured by a blood pressure monitor.
Measured: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Resting Heart Rate between Device Users and Non-Device Users
Resting heart rate (beats per minute) will be measured at assessment and near end of program completion
Measured: Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion)
Secondary outcomes (15)
Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and In-Person Patients
Change in Metabolic Equivalents measured during the baseline exercise stress test and discharge stress test.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Fat Intake Score Between Device Users and In-Person Patients
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Fibre Intake Score Between Device Users and In-Person Patients
Change in patient fibre intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Sodium Intake Score Between Device Users and In-Person Patients
Change in patient sodium intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Sugar Intake Score Between Device Users and In-Person Patients
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Quality of Life Ladder Score Between Device Users and In-Person Patients
Examine change in patient-reported quality of life using the Quality of Life Ladder at initial/baseline and discharge report.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Satisfaction with Life Between Device Users and In-Person Patients
Examine change in patient-reported quality of life using the Satisfaction with Life Scale at initial/baseline and discharge report.
Measured: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Triglyceride Level Change Between Device Users and In-Person Patients
Triglycerides (mmol/L) will be measured via standard blood panel.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Total Cholesterol Level Change Between Device Users and In-Person Patients
Total cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in HDL Cholesterol Level Change Between Device Users and In-Person Patients
HDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in LDL Cholesterol Level Change Between Device Users and In-Person Patients
LDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Hemoglobin A1C Level Change Between Device Users and In-Person Patients
HbA1C (%) will be measured via standard bloodwork.
Measured: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Systolic Blood Pressure Between Device Users and In-Person Patients
Systolic blood pressure (mmHg) measured by a blood pressure monitor.
Measured: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Diastolic Blood Pressure Between Device Users and In-Person Patients
Diastolic blood pressure (mmHg) measured by a blood pressure monitor.
Measured: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Resting Heart Rate between Device Users and In-Person Patients
Resting heart rate (beats per minute) will be measured at assessment and near end of program completion
Measured: Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Wearable DeviceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants enrolled in HEARTS in Sync program who use the Corsano CardioWatch 287-2 will be followed to evaluate the implementation and usability of the device into routine virtual cardiac rehabilitation care, as well as associated health outcomes. The health outcomes from participants in the clinical trial will be compared to two external control groups. First external control group consists of patients who are enrolled in usual care, virtual cardiac rehab program without the Corsano CardioWatch 287-2 device. The second external control group consists of patients who completed an on-site cardiac rehabilitation program. Both external control groups sign a program consent form that allows their data to be used for research purposes. This design allows for assessment of the device integration into usual care and its impact on patient outcomes in a real-world setting.
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Corsano Health B.V.
- Responsible party
- Principal investigator, Nicholas Giacomantonio, Nova Scotia Health Authority
- Investigators
- Nicholas B Giacomantonio, Medical Doctor, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322510
- Sponsor's protocol ID
- REB File No. 1032019
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corsano Health BV. CardioWatch 287-2 Bracelet & Mobile Patient App Instruction Manual.; 2024. www.corsano.com
van Vliet M, Monnink SHJ, Kuiper MJ, Constandse JC, Hoftijzer D, Ronner E. Evaluation of a novel cuffless photoplethysmography-based wristband for measuring blood pressure according to the regulatory standards. Eur Heart J Digit Health. 2024 Feb 8;5(3):335-343. doi: 10.1093/ehjdh/ztae006. eCollection 2024 May.
PubMed 38774367Blok S, Piek MA, Tulevski II, Somsen GA, Winter MM. The accuracy of heartbeat detection using photoplethysmography technology in cardiac patients. J Electrocardiol. 2021 Jul-Aug;67:148-157. doi: 10.1016/j.jelectrocard.2021.06.009. Epub 2021 Jul 2.
PubMed 34256184Monnink SHJ, van Vliet M, Kuiper MJ, Constandse JC, Hoftijzer D, Muller M, Ronner E. Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate. J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.
PubMed 39388061Stas P. Corsano Health Receives EU-MDR Certification. https://corsano.com/corsano-health-receives-eu-mdr-certification/.
Verhaar C. Corsano Health Receives FDA Clearance. https://corsano.com/28091-2/.
van Deudekom T. Corsano Health Receives ISO 13485 Certification. https://corsano.com/medical-certification/.
Jones AK, Yan CL, Rivera Rodriquez BP, Kaur S, Andrade-Bucknor S. Role of wearable devices in cardiac telerehabilitation: A scoping review. PLoS One. 2023 May 31;18(5):e0285801. doi: 10.1371/journal.pone.0285801. eCollection 2023.
PubMed 37256878Yeghiazarians Y, Jneid H, Tietjens JR, Redline S, Brown DL, El-Sherif N, Mehra R, Bozkurt B, Ndumele CE, Somers VK. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 Jul 20;144(3):e56-e67. doi: 10.1161/CIR.0000000000000988. Epub 2021 Jun 21.
PubMed 34148375Cheung C. The Emerging Role of Wearables in Cardiac Care. Vol 100.; 2023.
Pare G, Leaver C, Bourget C. Diffusion of the Digital Health Self-Tracking Movement in Canada: Results of a National Survey. J Med Internet Res. 2018 May 2;20(5):e177. doi: 10.2196/jmir.9388.
PubMed 29720359Bayoumy K, Gaber M, Elshafeey A, Mhaimeed O, Dineen EH, Marvel FA, Martin SS, Muse ED, Turakhia MP, Tarakji KG, Elshazly MB. Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol. 2021 Aug;18(8):581-599. doi: 10.1038/s41569-021-00522-7. Epub 2021 Mar 4.
PubMed 33664502Lear SA. The Delivery of Cardiac Rehabilitation Using Communications Technologies: The "Virtual" Cardiac Rehabilitation Program. Can J Cardiol. 2018 Oct;34(10 Suppl 2):S278-S283. doi: 10.1016/j.cjca.2018.07.009. Epub 2018 Jul 18.
PubMed 30274638Lam J, Ahmad K, Gin K, Chow CM. Deliver Cardiac Virtual Care: A Primer for Cardiovascular Professionals in Canada. CJC Open. 2022 Feb;4(2):148-157. doi: 10.1016/j.cjco.2021.10.001. Epub 2021 Oct 9.
PubMed 34661090Ramachandran HJ, Jiang Y, Tam WWS, Yeo TJ, Wang W. Effectiveness of home-based cardiac telerehabilitation as an alternative to Phase 2 cardiac rehabilitation of coronary heart disease: a systematic review and meta-analysis. Eur J Prev Cardiol. 2022 May 25;29(7):1017-1043. doi: 10.1093/eurjpc/zwab106.
PubMed 34254118
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Behaviour Change, Education on Risk Factor Reduction, Physical Activity Guidance, and Nutrition Counselling With a Remote Team to Support Patient Progress Using Technology in Synchronization With Medication Management and CardioWatch 287-2. (HEARTS in Sync + CardioWatch 287-2)
- ClinicalTrials.gov ID
- NCT07322510
- Acronym / sponsor ID
- REB File No. 1032019
- Keywords
- virtual cardiac rehabilitation, wearable device, remote monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Corsano Health B.V.
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 7 Jan 2026 (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 goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync. The question guiding this study is: Do patient clinical outcomes differ between those who use the CardioWatch 287-2 during the HEARTS in Sync program as compared to those who participate without using the CardioWatch 287-2? The comparison will happen between two non-randomized groups of patients who are enrolled in the HEARTS in Sync virtual CR program.
The wearable device (CardioWatch 287-2), worn on patient's wrists, will provide clinicians with physiological information to better mirror the clinical oversight provided to an in-person CR program. Participants who choose to use the device will be asked to wear it daily. The clinical team will review weekly summary reports to help guide participant progress through the 13-week program.
The primary objectives of this study are to:
- Characterize participants (e.g., demographic health history, patient feedback) between those who choose to use the CardioWatch 287-2 device and those who do not.
- Compare clinical outcomes between users and non-users of the device within the HEARTS in Sync program, by:
- Tracking patient enrollment, attendance in virtual education sessions, and program completion rates,
- Evaluating change in patient bloodwork outcomes,
- Measuring change is physical ability,
- Analyzing changes in eating behaviours, and
- Examining quality of life using validated tools.
- Asses the feasibility of the CardioWatch 287-2 for the HEARTS in Sync virtual CR program by:
- Assessing device adherence
- Reviewing patient feedback survey, and
- Determining if clinician team were able to access and interpret data collected throughout the program
The secondary objective of this study is to compare clinical outcomes of device users during the HEARTS in Sync program with patients who completed the on-site CR program.
This research aims to better understand how a medical-grade device may improve virtual CR programming to extend clinical care to the community. As a result, this could lead to a more personalized care and better results for patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants enrolled in HEARTS in Sync program who use the Corsano CardioWatch 287-2 will be followed to evaluate the implementation and usability of the device into routine virtual cardiac rehabilitation care, as well as associated health outcomes. The health outcomes from participants in the clinical trial will be compared to two external control groups. First external control group consists of patients who are enrolled in usual care, virtual cardiac rehab program without the Corsano CardioWatch 287-2 device. The second external control group consists of patients who completed an on-site cardiac rehabilitation program. Both external control groups sign a program consent form that allows their data to be used for research purposes. This design allows for assessment of the device integration into usual care and its impact on patient outcomes in a real-world setting.
| Arm | Type | Receives |
|---|---|---|
| Virtual Cardiac Rehab + Corsano CardioWatch 287-2 | Experimental | Device: Remote Patient Monitoring with Corsano CardioWatch 287-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who meet CR inclusion criteria requirements and who are enrolling in virtual cardiac rehab program, HEARTS in Sync, in Nova Scotia.
Key exclusion criteria (8 listed)
- Phones that are not compatible with the Corsano system.
- Huawei P8 Lite
- Huawei P9 Lite
- Xiaomi Mi 6
- Huawei P20 Lite
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 |
|---|---|---|
| Remote Patient Monitoring with Corsano CardioWatch 287-2Participants wear a CardioWatch 287-2 during the 13-week virtual cardiac rehabilitation program, HEARTS in Sync. The program is delivered by the Nova Scotia Health clinical team that consists of a Registered Nurse, Registered Dietitian and Physiotherapist. The CardioWatch 287-2 collects health information such as pulse rate, blood pressure, sleep, steps, activity, and more. This information is available for participants to check on the patient app called "Corsano". The information is also summarized on a weekly report that reports 7-day average which the clinical team will review on the Healthcare Practitioner web-based portal. This information is used to guide the participants rehabilitation journey. These participants will be followed to understand program adherence, patient-reported usability and acceptability, and clinical outcomes collected at baseline and program discharge. | Device | Virtual Cardiac Rehab + Corsano CardioWatch 287-2 |
Primary outcome
Patient Program Adherence
Time frame: From enrollment to 13-week program completion
The proportion (%) of program sessions attended by each patient, comparing device users and non-device user. Attendance percentage will be obtained by program records.
Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Metabolic Equivalents measured during the baseline exercise stress test and discharge stress test.
Change in Fat Intake Score Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Fibre Intake Score Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient fibre intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Sodium Intake Score Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient sodium intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Sugar Intake Score Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in patient fat intake score measured using a validated nutrition questionnaire at baseline and discharge.
Change in Quality of Life Ladder Score Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Examine change in patient-reported quality of life using the Quality of Life Ladder at initial/baseline and discharge report.
Change in Satisfaction with Life Between Device Users and Non-Device Users
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Examine change in patient-reported quality of life using the Satisfaction with Life Scale at initial/baseline and discharge report.
Characterize Participants
Time frame: Initial (at assessment)
Determine demographic and health history between device users and non-device users
Device Adherence to Wearing the CardioWatch 287-2
Time frame: From enrollment to the end of the program at 13-weeks
Device adherence will be assessed by calculating the proportion of total study days during which each participant wore the device for the required monitoring duration. Adherence will be categorized into one of the three following groups: 1. High compliance: ≥ 50% daily wear time (~12 hours/day on all 7 days/week) 2. Moderate compliance: ≥ 25% daily wear time (~6 hours/day) 3. Low compliance: ≥ 12.5% daily wear time (~3 hours/day) The unit of measure is percentage (%) of days with required wear time and proportion (%) of participants in each adherence category. Device adherence is automatically captured through the Corsano CardioWatch 287-2 system.
Patient-Reported Usability and Acceptability of the CardioWatch 287-2
Time frame: After completion of the program (e.g. after 13 weeks)
Participants' perceptions of usability, comfort, and acceptability of the device will be assessed using a study-specific questionnaire that includes both participant rating scale and free-text responses. Only the ranked items will be used for quantitative outcome reporting while the free-text responses will be summarized descriptively.
Clinician-Reported Usability of the CardioWatch 287-2 System
Time frame: Up to 1 year after study completion
Clinicians' assessment of device usability including ease of data interpretation, integration into clinical workflow, and perceived clinical value. This will be a descriptive analysis only captured through a study-specific focus group.
Change in Triglyceride Level Change Between Device Users and Non-Device Users
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Triglycerides (mmol/L) will be measured via standard blood panel.
Change in Total Cholesterol Level Change Between Device Users and Non-Device Users
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Total cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Change in HDL Cholesterol Level Change Between Device Users and Non-Device Users
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
HDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Change in LDL Cholesterol Level Change Between Device Users and Non-Device Users
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
LDL cholesterol (mmol/L) will be measured via lipid panel in bloodwork.
Change in Hemoglobin A1C Level Change Between Device Users and Non-Device Users
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
HbA1C (%) will be measured via standard bloodwork.
Change in Systolic Blood Pressure Between Device Users and Non-Device Users
Time frame: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Systolic blood pressure (mmHg) measured by a blood pressure monitor.
Change in Diastolic Blood Pressure Between Device Users and Non-Device Users
Time frame: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Diastolic blood pressure (mmHg) measured by a blood pressure monitor.
Change in Resting Heart Rate between Device Users and Non-Device Users
Time frame: Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion)
Resting heart rate (beats per minute) will be measured at assessment and near end of program completion
15 secondary outcomes
Change in Metabolic Equivalents (METs) from Baseline to Discharge Between Device Users and In-Person Patients
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Fat Intake Score Between Device Users and In-Person Patients
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Fibre Intake Score Between Device Users and In-Person Patients
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Sodium Intake Score Between Device Users and In-Person Patients
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Sugar Intake Score Between Device Users and In-Person Patients
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Quality of Life Ladder Score Between Device Users and In-Person Patients
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Satisfaction with Life Between Device Users and In-Person Patients
Time frame: Baseline (after program assessment but before program start) and Discharge (near program completion, up to 6 weeks after program end)
Change in Triglyceride Level Change Between Device Users and In-Person Patients
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Total Cholesterol Level Change Between Device Users and In-Person Patients
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in HDL Cholesterol Level Change Between Device Users and In-Person Patients
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in LDL Cholesterol Level Change Between Device Users and In-Person Patients
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Hemoglobin A1C Level Change Between Device Users and In-Person Patients
Time frame: Baseline (after assessment but before program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Systolic Blood Pressure Between Device Users and In-Person Patients
Time frame: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Diastolic Blood Pressure Between Device Users and In-Person Patients
Time frame: Baseline (between assessment and program start) and Discharge (near end of program or up to 6 weeks after program completion)
Change in Resting Heart Rate between Device Users and In-Person Patients
Time frame: Initial (at assessment) and Discharge (near end of program completion, up to 6 weeks after program completion)
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 7 Jan 2026.
- BackgroundCorsano Health BV. CardioWatch 287-2 Bracelet & Mobile Patient App Instruction Manual.; 2024. www.corsano.com
- Background: PubMed 38774367van Vliet M, Monnink SHJ, Kuiper MJ, Constandse JC, Hoftijzer D, Ronner E. Evaluation of a novel cuffless photoplethysmography-based wristband for measuring blood pressure according to the regulatory standards. Eur Heart J Digit Health. 2024 Feb 8;5(3):335-343. doi: 10.1093/ehjdh/ztae006. eCollection 2024 May.
- Background: PubMed 34256184Blok S, Piek MA, Tulevski II, Somsen GA, Winter MM. The accuracy of heartbeat detection using photoplethysmography technology in cardiac patients. J Electrocardiol. 2021 Jul-Aug;67:148-157. doi: 10.1016/j.jelectrocard.2021.06.009. Epub 2021 Jul 2.
- Background: PubMed 39388061Monnink SHJ, van Vliet M, Kuiper MJ, Constandse JC, Hoftijzer D, Muller M, Ronner E. Clinical evaluation of a smart wristband for monitoring oxygen saturation, pulse rate, and respiratory rate. J Clin Monit Comput. 2025 Apr;39(2):451-457. doi: 10.1007/s10877-024-01229-z. Epub 2024 Oct 10.
- BackgroundStas P. Corsano Health Receives EU-MDR Certification. https://corsano.com/corsano-health-receives-eu-mdr-certification/.
- BackgroundVerhaar C. Corsano Health Receives FDA Clearance. https://corsano.com/28091-2/.
- Backgroundvan Deudekom T. Corsano Health Receives ISO 13485 Certification. https://corsano.com/medical-certification/.
- Background: PubMed 37256878Jones AK, Yan CL, Rivera Rodriquez BP, Kaur S, Andrade-Bucknor S. Role of wearable devices in cardiac telerehabilitation: A scoping review. PLoS One. 2023 May 31;18(5):e0285801. doi: 10.1371/journal.pone.0285801. eCollection 2023.
- Background: PubMed 34148375Yeghiazarians Y, Jneid H, Tietjens JR, Redline S, Brown DL, El-Sherif N, Mehra R, Bozkurt B, Ndumele CE, Somers VK. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 Jul 20;144(3):e56-e67. doi: 10.1161/CIR.0000000000000988. Epub 2021 Jun 21.
- BackgroundCheung C. The Emerging Role of Wearables in Cardiac Care. Vol 100.; 2023.
- Background: PubMed 29720359Pare G, Leaver C, Bourget C. Diffusion of the Digital Health Self-Tracking Movement in Canada: Results of a National Survey. J Med Internet Res. 2018 May 2;20(5):e177. doi: 10.2196/jmir.9388.
- Background: PubMed 33664502Bayoumy K, Gaber M, Elshafeey A, Mhaimeed O, Dineen EH, Marvel FA, Martin SS, Muse ED, Turakhia MP, Tarakji KG, Elshazly MB. Smart wearable devices in cardiovascular care: where we are and how to move forward. Nat Rev Cardiol. 2021 Aug;18(8):581-599. doi: 10.1038/s41569-021-00522-7. Epub 2021 Mar 4.
- 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.
Nicholas B Giacomantonio, Medical Doctor principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Patient Monitoring with Corsano CardioWatch 287-2 in people with Wearable Device and Cardiovascular Disease, run by Nova Scotia Health Authority at 1 site in Canada.
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 1 inclusion and 8 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 7 Jan 2026. 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 Canada. 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 Erin N Welsh, PhD (9027170603, erin.welsh@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Program Adherence (time frame: From enrollment to 13-week program completion). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07322510, which also lists 27 linked publications.
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 7 Jan 2026.