Remote Monitoring for Cardiovascular Disease

EN
BL
Overseen ByBrittany L Bhatnagar, MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a wearable device called Corsano CardioWatch 287-2 for individuals in a virtual heart rehab program. The researchers aim to determine if using the device improves health outcomes, such as physical ability and quality of life, compared to not using it. Participants enrolled in the HEARTS in Sync virtual cardiac rehab program who own a compatible device might be suitable candidates. The study seeks to understand if this device can enhance remote heart care. As an unphased trial, it offers a unique opportunity to contribute to innovative heart care solutions and potentially enhance participants' health journeys.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the clinical team before participating.

What prior data suggests that the CardioWatch 287-2 device is safe for use in cardiac rehabilitation?

Research has shown that the Corsano CardioWatch 287-2 is safe under normal conditions. This device tracks health information such as heart rate and blood pressure and can be used daily without special precautions. Safety information indicates no risks unless an unusual event occurs, like a rare acid leak from the device, which is not expected during regular use.

Previous studies have found the device effective for monitoring heart health. No common negative effects have been reported, suggesting it is generally well-tolerated. Although clinical trials specifically for this device have not been detailed, its design and purpose suggest it is as safe to wear as other fitness and health trackers available.12345

Why are researchers excited about this trial?

Unlike traditional treatments for cardiovascular disease, which often involve in-person cardiac rehab sessions, the Corsano CardioWatch 287-2 offers a remote monitoring solution. This wearable device allows for continuous tracking of heart health metrics in real-time, making it easier and more convenient for patients to stay engaged with their cardiac care from the comfort of their home. Researchers are excited about this approach because it has the potential to increase patient compliance, provide more personalized care, and deliver timely interventions, ultimately improving heart health outcomes.

What evidence suggests that the CardioWatch 287-2 is effective for cardiovascular disease?

Research shows that the CardioWatch 287-2 effectively tracks heart health. It monitors key indicators like heart rate, oxygen levels, and activity, offering a comprehensive view of a person's health. Studies have found that this device can replace traditional methods for checking high blood pressure. In this trial, participants will use the CardioWatch 287-2 as part of the Virtual Cardiac Rehab program. By providing real-time data, continuous monitoring with the CardioWatch 287-2 may improve health outcomes for patients. This device could also enhance online heart rehab programs, aiding patients in improving their health.26789

Who Is on the Research Team?

NB

Nicholas B Giacomantonio, Medical Doctor

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for patients in Nova Scotia who qualify for cardiac rehab and are enrolling in the HEARTS in Sync virtual program. It's not specified who can't join, but typically those not meeting CR criteria would be excluded.

Inclusion Criteria

I am eligible for cardiac rehab and enrolling in the HEARTS in Sync program in Nova Scotia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 13-week virtual Cardiac Rehabilitation program, with or without the CardioWatch 287-2 device

13 weeks
Weekly virtual check-ins

Follow-up

Participants are monitored for changes in clinical outcomes and quality of life after program completion

6 weeks
Virtual follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Corsano CardioWatch 287-2

Trial Overview

The study tests if using the CardioWatch 287-2 wearable device affects clinical outcomes of patients in a virtual Cardiac Rehabilitation (CR) program compared to those without it. The device provides physiological data to clinicians over a 13-week course.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Virtual Cardiac Rehab + Corsano CardioWatch 287-2Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Corsano Health B.V.

Industry Sponsor

Trials
5
Recruited
420+

Citations

NCT07322510 | 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 ...

Corsano's CardioWatch 287-2 System

Corsano's CardioWatch 287-2 is a transformative solution for hypertension monitoring, highlighting its potential to replace traditional 24-hour ABPM.

HEARTS in Sync + CardioWatch 287-2 | MedPath

The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual ...

Validation of the CardioWatch 287-2 Pulse Rate Algorithm

Wearable technology like the CardioWatch 287-2 provides a convenient, non-invasive method for continuous monitoring, significantly improving patient outcomes ...

Continuous Remote Patient Monitoring

Corsano CardioWatch 287 is a wristband that tracks pulse rate, saturation, respiration rate and other parameters, like core body temperature and activity ...

Corsano CardioWatch 287-2 Safety Data Sheet

No control for exposure is needed under normal use conditions. In case of acid leak, dust or smoke, wear protection gloves, protection glasses ...

Corsano Health Cardiowatch 287 USA Usability Study

The Corsano Cardiowatch 287 bracelet is a wrist wearable device, monitoring multiple sensors including, PhotoPlethysmography (PPG), accele- rometer, temperature ...

Blood Pressure Treatment by the Corsano CardioWatch ...

The Remote Cardiac Monitoring (RECAMO) study is underway to assess the free-living remote care setting long-term monitoring validity using a static test.

Resources

Corsano's CardioWatch 287-2 is a transformative solution for hypertension monitoring, highlighting its potential to replace traditional 24-hour ABPM. Read More.