Wireless Handheld 8-lead ECG Device Performance in Heart Patients (Rapid Rhythm)

Performance Evaluation Study of a Six Electrode (8 Lead) Wireless Handheld ECG Recording Device With Four Lead Chest Extension Versus Conventional 12-lead ECG in Heart Patients

This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device with the conventional 12 lead ECG. As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Heart Murmurs
• Intervention / Treatment: Device: Rapid Rhythm Handheld 8-lead ECG Device

Detailed Description

An Electrocardiogram (ECG) 6 electrode, wireless handheld device held on the chest is being developed to allow diagnosis of heart rhythm problems without the need for connecting electrodes to the chest, arms and legs as in a standard 10 electrode (referred to as a 12-lead) ECG measurement. A faster and simpler yet accurate method for acquiring ECG data may be useful in many healthcare settings, including screening for irregular heart rhythms such as Atrial Fibrillation (AF), which is a risk factor for stroke. The wireless 6 electrode device has an extension arm for the handset with 4 additional electrodes (also positioned on the chest) to give a full 12 lead ECG signal. This study is designed to compare the performance of both 6 and 10 electrode ECGs from the handheld device (used on the chest with the subject seated) with the conventional 12 lead ECG (used with electrodes on the chest, arms and legs with the subject lying down). As well as comparing the detection of atrial fibrillation, the study will also compare the detection of other heart problems and of normal heart rhythm. Adult patients attending the clinics at Central Manchester University Hospitals NHS Foundation Trust for an ECG assessment are eligible to participate in the study. A maximum of 500 patients will be recruited to the study in order to find the number of cases with Atrial Fibrillation required to properly compare the methods. A subset of patients with normal ECGs will have additional measurements with both methods whilst lying down, reclining at an angle and sitting upright to investigate any effects of body posture on chest based ECGs.

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient attending an adult cardiology or anti-coagulation clinic appointment, at clinics at Central Manchester University Hospitals NHS Foundation Trust (including the Manchester Heart Centre).
2. Patients on cardiac wards 3 and 4.
3. Aged 18 years or above.
4. Male or Female.

Exclusion Criteria:

1. Aged less than 18 years.
2. Unable to give informed consent.
3. Does not wish to participate in the study.
4. Any patients with visible breaks to the skin, rashes or inflammation in the chest area on the day of the test
5. Bedridden or otherwise unable to transfer between chair and bed for both seated and supine measurements

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Rapid Rhythm Handheld 8-lead ECG Device; Participants will have measurements taken with the 8 lead ECG system, which will be compared to the conventional standard care 12 lead ECG.

Device: Rapid Rhythm Handheld 8-lead ECG Device; We want to explore whether using 6 electrodes on the chest (as in the Rapid Rhythm Handheld 8-lead ECG device) can give the same diagnostic result to the standard 10 electrode (12-lead) ECG, which uses 6 chest electrodes plus 4 electrodes on the arms and legs. To do this we need to compare measurements taken with the 6 electrode (8 lead) study device to those taken with the gold-standard 10 electrode (12 lead) method. We want to find out whether the new equipment can detect the same heart rhythms as the standard method, so that ECG measurements might be made more quickly and easily in the future.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capabilities of an 8 lead ECG system (Rapid Rhythm) - normal ECGs	The percentage of ECGs where a normal control ECG is matched by a normal RR ECG.	18 months
Capabilities of an 8 lead ECG system (Rapid Rhythm) - abnormal ECGs	The percentage of ECGs where abnormalities of the control ECG are matched by similar abnormalities of the RR ECG.	18 months

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Collaborators: Rapid Rhythm Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2017
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Heart Murmurs
• Other Study ID Numbers: 160483; R04118 (OTHER: Central Manchester University Hospitals NHS Foundation Trust)

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