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

NCT03501836 | Completed

• 2 other identifiers: 160483R04118
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Heart Murmurs

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Rapid Rhythm Handheld 8-lead ECG Device

EXPERIMENTAL

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

Interventions

Rapid Rhythm Handheld 8-lead ECG Device 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.

Rapid Rhythm Handheld 8-lead ECG Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients on cardiac wards 3 and 4.
• Aged 18 years or above.
• Male or Female.

You may not qualify if:

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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Rapid Rhythm Ltd: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Murmurs

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 18, 2018
• Study Start: January 24, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)