Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smartwatch iECG for the Detection of Cardiac Arrhythmias

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date September 16, 2019
First Posted Date September 17, 2019
Last Update Posted Date January 2, 2020
Actual Study Start Date September 30, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 16, 2019)
  • Level of agreement between the cardiologist's interpretations of the 12-lead ECG and the ECG App interpretation results [ Time Frame: Baseline ]
  • Level of agreement between the cardiologist's interpretations of the 12-lead ECG and iECG [ Time Frame: Baseline ]
  • Level of agreement between the cardiologist's interpretations of the iECG and the ECG App interpretation results [ Time Frame: Baseline ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 16, 2019)
  • Proportion of participants that remain in arrhythmia diagnosis, from the positive diagnosis from the iECG to the performed 12-lead ECG [ Time Frame: Baseline ]
  • Proportion of interpretable and non-interpretable iECGs [ Time Frame: 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 ]
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Smartwatch iECG for the Detection of Cardiac Arrhythmias
Official Title Feasibility and Reliability of Smartwatch iECG for the Detection of Cardiac Arrhythmias (The Leipzig Apple Heart Rhythm Study)
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All individuals who had been admitted to the Department of Electrophysiology, Leipzig Heart Center
Condition
  • Arrhythmias, Cardiac
  • Atrial Fibrillation
Intervention 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
Study Groups/Cohorts Patients suspected with Cardiac Arrhythmia
iECG + 12-lead ECG recording in patients suspected with any type of cardiac arrhythmias at the time of recruitment
Intervention: Device: iECG recording
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 16, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04092985
Other Study ID Numbers 2019-0157
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Leipzig Heart Institute GmbH
Study Sponsor Leipzig Heart Institute GmbH
Collaborators Heart Center Leipzig - University Hospital
Investigators
Study Chair: Andreas Bollmann, MD, PhD Heart Center Leipzig at University of Leipzig, Leipzig Heart Institute, Germany
PRS Account Leipzig Heart Institute GmbH
Verification Date December 2019