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

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03501836
Study type	Interventional
Source	Manchester University NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	January 24, 2017
Completion date	June 30, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Completed	`NCT04571385` - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)	Phase 2
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Completed	`NCT05366803` - Women's Health Initiative Silent Atrial Fibrillation Recording Study	N/A
Completed	`NCT02864758` - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting	`NCT05442203` - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease	N/A
Completed	`NCT05599308` - Evaluation of Blood Pressure Monitor With AFib Screening Feature	N/A
Completed	`NCT03790917` - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation	`NCT05890274` - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO	N/A
Recruiting	`NCT05266144` - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting	`NCT05316870` - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation	N/A
Not yet recruiting	`NCT06023784` - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Recruiting	`NCT04092985` - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed	`NCT04087122` - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures	N/A
Completed	`NCT06283654` - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04546763` - Study Watch AF Detection At Home
Completed	`NCT03761394` - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms