- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04092985
Smart Watch iECG for the Detection of Cardiac Arrhythmias
Feasibility and Reliability of Smart Watch iECG for the Detection of Cardiac Arrhythmias (The Leipzig Apple Heart Rhythm Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This diagnostic accuracy study is an investigator-initiated trial to evaluate the value of a smart watch-based iECG for detection of cardiac arrhythmias.
iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the market version of the ECG application (Apple Inc., California). Participants will be advised to lie down in a supine position and breathe spontaneously. All recording will be done by trained study personnel.
All iECG and 12-lead ECG recordings will be presented in PDF format as our references. Saved formats will be transferred to our Telemonitoring Center for further analysis and processing.
Results from a 12-lead ECG will be considered as the gold standard for the measurement of heart rhythms and the arrhythmia diagnosis. All 12-lead ECGs recordings will be analyzed by 2 blinded cardiologists and will be categorized as "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, cardiologists will report ECG wave's characteristics as well as any other possible diagnosis including "Superior ventricular tachycardia", "Ventricular tachycardia", "Atrial flutter", and "other types: other possible arrhythmias". In the case of uncertainties, a third cardiologist will be consulted, blinded for initial diagnoses.
The iECG recordings (test index) will be interpreted and reported in two different ways:
- By using HealthKit Framework (Apple Watch and Apple iPhone applications): After a successful iECG recording with the Apple watch, iECGs will be transmitted by the ECG application to the iPhone. The Health App (Apple Inc., California) will receive, process and store the iECGs on the iPhone and will present one of the following results on the iPhone screen automatically: "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, the mean heart rate will be recorded, which will be automatically calculated by the Health App.
- By cardiologist: All iECGs will be analyzed by 2 blinded cardiologists. They will report their findings in the following categorize: "Sinus rhythm", "High or low heart rate", "Atrial fibrillation", or "Inconclusive". Besides, they will report ECG wave's characteristics as well as any other possible diagnosis including "Superior ventricular tachycardia", "Ventricular tachycardia", "Atrial flutter", and "other types: other possible arrhythmias". In the case of uncertainties, a third cardiologist will be consulted, blinded for initial diagnoses.
ECG wave's characteristics: The following variables will be measured as the iECG and 12-lead ECG waves' characteristics. Three randomly chosen heartbeats will be considered to measure each wave or interval, and the mean of these 3 measurements will be used for statistical analysis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Andreas Bollmann, MD, PhD
- Phone Number: +49341865-0
- Email: Andreas.Bollmann@helios-gesundheit.de
Study Contact Backup
- Name: Alireza Sepehri Shamloo, MD
- Phone Number: +49341865-0
- Email: Alireza.Sepehri-Shamloo@helios-gesundheit.de
Study Locations
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-
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Leipzig, Germany, 04289
- Recruiting
- Andreas Bollmann
-
Contact:
- Andreas Bollmann, MD, PhD
- Email: andreas.bollmann@helios-gesundheit.de
-
Contact:
- Alireza Sepehri Shamloo, MD
- Email: Alireza.Sepehri-Shamloo@helios-gesundheit.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged≥22 years at the time of eligibility screening will be included.
- Patients with known cardiac arrhythmias; i.e. AF before and after cardioversion, hemodynamically stable Bradycardias, SVT and VT during EP procedures and implants can also be included
Exclusion Criteria:
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients suspected with Cardiac Arrhythmia
iECG + 12-lead ECG recording in patients suspected with any type of cardiac arrhythmias at the time of recruitment
|
iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results
Time Frame: Baseline
|
Baseline
|
Level of agreement between the cardiologist's interpretations of the 12-lead ECG and iECG
Time Frame: Baseline
|
Baseline
|
Level of agreement between the cardiologist's interpretations of the iECG and the ECG App interpretation results
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of participants that remain in arrhythmia diagnosis, from the positive diagnosis from the iECG to the performed 12-lead ECG
Time Frame: Baseline
|
Baseline
|
Proportion of interpretable and non-interpretable iECGs
Time Frame: Baseline
|
Baseline
|
Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: cardiologists interpretation of iECG (index test) and 12-lead ECGs (reference test)
Time Frame: Baseline
|
Baseline
|
Sensitivity and specificity of screening tests for cardiac arrhythmias identification using: ECG App interpretation results (index test) and 12-lead ECGs (reference test)
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Andreas Bollmann, MD, PhD, Heart Center Leipzig at University of Leipzig, Leipzig Heart Institute, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0157
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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