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Smartwatch iECG for the Detection of Cardiac Arrhythmias

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ClinicalTrials.gov Identifier: NCT04092985
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
Heart Center Leipzig - University Hospital
Information provided by (Responsible Party):
Leipzig Heart Institute GmbH

Brief Summary:
This study aims to assess the feasibility and reliability of smartwatch iECG provided by the Apple Watch/Apple iPhone for the detection of different cardiac arrhythmias. In this study, results from a 12-lead ECG will be set as the gold standard for the arrhythmia diagnosis, and results from the smartwatch iECG (Apple watch/Apple iPhone application and Cardiologist's interpretations) as the index tests. The 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 smartwatch (Apple Watch Series 4) with the ECG application.

Condition or disease Intervention/treatment
Arrhythmias, Cardiac Atrial Fibrillation Device: iECG recording

Detailed Description:

This diagnostic accuracy study is an investigator-initiated trial to evaluate the value of a smartwatch-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 smartwatch (Apple Watch Series 4) with the market version of the ECG application (Apple Inc., Cupertino, 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:

  1. 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., Cupertino, 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.
  2. 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility and Reliability of Smartwatch iECG for the Detection of Cardiac Arrhythmias (The Leipzig Apple Heart Rhythm Study)
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

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
Device: iECG recording
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 smartwatch (Apple Watch Series 4) with the ECG application




Primary Outcome Measures :
  1. Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results [ Time Frame: Baseline ]
  2. Level of agreement between the cardiologist's interpretations of the 12-lead ECG and iECG [ Time Frame: Baseline ]
  3. Level of agreement between the cardiologist's interpretations of the iECG and the ECG App interpretation results [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Proportion of participants that remain in arrhythmia diagnosis, from the positive diagnosis from the iECG to the performed 12-lead ECG [ Time Frame: Baseline ]
  2. Proportion of interpretable and non-interpretable iECGs [ Time Frame: Baseline ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All individuals who had been admitted to the Department of Electrophysiology, Leipzig Heart Center
Criteria

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


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): NCT04092985


Contacts
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Contact: Andreas Bollmann, MD, PhD +49341865-0 Andreas.Bollmann@helios-gesundheit.de
Contact: Alireza Sepehri Shamloo, MD +49341865-0 Alireza.Sepehri-Shamloo@helios-gesundheit.de

Locations
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Germany
Andreas Bollmann Recruiting
Leipzig, Germany, 04289
Contact: Andreas Bollmann, MD, PhD       andreas.bollmann@helios-gesundheit.de   
Contact: Alireza Sepehri Shamloo, MD       Alireza.Sepehri-Shamloo@helios-gesundheit.de   
Sponsors and Collaborators
Leipzig Heart Institute GmbH
Heart Center Leipzig - University Hospital
Investigators
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Study Chair: Andreas Bollmann, MD, PhD Heart Center Leipzig at University of Leipzig, Leipzig Heart Institute, Germany

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Responsible Party: Leipzig Heart Institute GmbH
ClinicalTrials.gov Identifier: NCT04092985    
Other Study ID Numbers: 2019-0157
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Leipzig Heart Institute GmbH:
Arrhythmias, Cardiac
Cardiovascular App
Rhythm monitoring
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes