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

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ClinicalTrials.gov Identifier: NCT03501836
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
Rapid Rhythm Ltd
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Heart Murmurs Device: Rapid Rhythm Handheld 8-lead ECG Device Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Capabilities of an 8 lead ECG system (Rapid Rhythm) - normal ECGs [ Time Frame: 18 months ]
    The percentage of ECGs where a normal control ECG is matched by a normal RR ECG.

  2. Capabilities of an 8 lead ECG system (Rapid Rhythm) - abnormal ECGs [ Time Frame: 18 months ]
    The percentage of ECGs where abnormalities of the control ECG are matched by similar abnormalities of the RR ECG.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501836


Contacts
Contact: Sarah Mackie +441612763336 sarah.mackie@mft.nhs.uk

Locations
United Kingdom
Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Sarah Mackie    +441612763336    sarah.mackie@mft.nhs.uk   
Principal Investigator: Fozia Ahmed         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Rapid Rhythm Ltd

Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03501836     History of Changes
Other Study ID Numbers: 160483
R04118 ( Other Identifier: Central Manchester University Hospitals NHS Foundation Trust )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Murmurs
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Signs and Symptoms