REmote CArdiac MOnitoring by the Corsano CardioWatch 287-2 Evaluation Study (RECAMO)

Remote Cardiac Monitoring by the Corsano CardioWatch 287-2 Evaluation Study

In this study, a wristband that monitors hearth rhythm and blood pressure is assessed in free living conditions.

Two groups of patients are being recruited: patients receiving an EKG holter and patients receiving an automatic blood pressure monitor. Patients wear the wristband for 28 days. During this time, the number of atrial fibrillation episodes detected by the wristband is being counted, which is to be compared with the number of episodes detected by the holter. Also, blood pressure is measured continuously, which is to be compared with daily blood pressure measurements using a conventional blood pressure cuff.

Study Overview

• Status: Completed
• Conditions: Hypertension; Atrial Fibrillation; Hypotension; Palpitations; Rhythm; Disorder
• Intervention / Treatment: Device: Corsano CardioWatch 287-2

Detailed Description

Background of the study:

Wearables have the potential to monitor patients remotely. The Corsano CardioWatch 287-2 is such a medical device that can monitor atrial fibrillation and long-term blood pressure. The device has been validated using clinical trials in hospitals, but validation in the intended remote setting is lacking.

Objective of the study:

Primary objective: To compare the number of episodes of atrial fibrillation detected by the Corsano CardioWatch 287-2 during 28 days of use with the number of episodes of atrial fibrillation detected by conventional Holter monitoring during 48 hours of use (standard care).

Secondary objective: To assess the difference in blood pressure measurements obtained by the Corsano CardioWatch 287-2 and the conventional cuff blood pressure monitor over a period of 28 days; to assess the usability of the Corsano CardioWatch 287-2 from a patient perspective.

Study design:

Group A:

Conventional 24 hour EKG holter monitoring will be compared to 28 day continuous monitoring by the Corsano CardioWatch 287-2 to assess whether the percentage of patients in whom atrial fibrillation is detected will increase. Detection of atrial fibrillation with the Corsano CardioWatch 287-2 is done by optical photoplethysmography (PPG), after which atrial fibrillation is confirmed with a 30-second ECG measurement.

Additionally, conventional cuff blood pressure will be compared to blood pressure measured by the Corsano CardioWatch 287-2 to validate free-living blood pressure monitoring. Patients will measure their blood pressure daily with a cuff blood pressure measurement device. The measurements at day 7, 14, 21 will be used to reinforce the Corsano blood pressure algorithm. The remaining measurements will be used to compare the blood pressure with the values measured by the Corsano CardioWatch 287-2 to assess accuracy.

Group B:

Conventional automatic cuff blood pressure measurement will be compared with the Corsano CardioWatch 287-2 for 24-48 hours. The automatic cuff blood pressure monitor will take a blood pressure reading every 30 minutes. Each reading will be compared with the Corsano CardioWatch 287-2 reading.

Study population:

Patients receiving a 24 hour EKG holter or an ambulant blood pressure device after visiting the cardiologist's outpatient clinic.

Primary study parameters/outcome of the study:

Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.

Secundary study parameters/outcome of the study (if applicable):

1. Mean blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.
2. Usability of the Corsano CardioWatch 287-2 in a remote care setting as determined by a questionnaire.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

At the cardiologist's office, Group A and B patients receive 3 blood pressure measurements. These are performed by a nurse. Group A will take daily blood pressure readings of themselves at home. If atrial fibrillation is detected by the wristband, Group A patients will be asked to take an ECG. Finally, Group A patients will be asked once to complete a questionnaire. Group B only has to wear the wristband for 24 to 48 hours as an additional burden in addition to the aforementioned initial measurements.

• Study Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Delft, Zuid Holland, Netherlands, 2625 AD
      • Reinier de Graaf Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

One group (A) receiving an EKG monitoring holter for the duration of 24 hours as part of standard care for atrial fibrillation screening. Besides, one group (B) receiving an automatic blood pressure cuff for the duration of 24 hours as part of standard care for blood pressure evaluation.

Description

Inclusion Criteria:

• ≥ 18 years old;
• able to provide consent;
• receiving EKG holter or automatic blood pressure cuff for home monitoring per doctor prescription

Exclusion Criteria:

• Unable to wear the Corsano CardioWatch 287 due to reasons such as allergic reactions, wounds, amputations etc.;
• Unable to receive blood pressure measurements per cuff due to lymphedema, amputation, dialysis shunt, wounds, etc.;
• Pregnant women;
• Breastfeading women;
• Upper arm circumference not within the cuff range (22-42 cm)
• Unable or not willing to sign informed consent;
• Significant mental or cognitive impairment.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving an EKG holter; patients receiving an EKG holter at the outpatient clinic for 24-48 hours of remote monitoring	Device: Corsano CardioWatch 287-2; Patients receive either an EKG holter or an automatic blood pressure cuff, as prescribed by their cardiologist. The readings from these devices (atrial fibrillation detection and blood pressure) will be compared to the readings from the CardioWatch 287-2.
Patients receiving an automatic blood pressure cuff; patients receiving an automatic blood pressure cuff at the outpatient clinic for 24 hours of remote monitoring	Device: Corsano CardioWatch 287-2; Patients receive either an EKG holter or an automatic blood pressure cuff, as prescribed by their cardiologist. The readings from these devices (atrial fibrillation detection and blood pressure) will be compared to the readings from the CardioWatch 287-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation detection rate	Absolute percentage increase of patients in whom at least one event of atrial fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of monitoring, compared to a conventional EKG holter during 24-48 hours of monitoring.	28 days
Blood pressure accuracy	Mean systolic and diastolic blood pressure difference and its SD between blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.	28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure accuracy	Bias and limits of agreement between systolic and diastolic blood pressure measured by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional oscillometric blood pressure cuff.	28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)
Usability questionnaire	Usability of the Corsano CardioWatch 287-2 in a remote care setting as assessed by a self-developed questionnaire	28 days (EKG holter group) or 1-2 days (Automatic blood pressure group)

Collaborators and Investigators

• Sponsor: Corsano Health B.V.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; hypertension; wearable; blood pressure; comparison; wristband; ekg
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hypertension; Atrial Fibrillation; Arrhythmias, Cardiac; Hypotension
• Other Study ID Numbers: RECAMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No