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History of Changes for Study: NCT04842123
Electrocardiogram Clinical Validation Study
Latest version (submitted February 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 8, 2021 None (earliest Version on record)
2 February 2, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Changes (Merged) for Study: NCT04842123
April 8, 2021 (v1) -- February 2, 2022 (v2)

Changes in: Study Status, Study Design and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: ECG-002
Brief Title: Electrocardiogram Clinical Validation Study
Official Title: Electrocardiogram Clinical Validation Study
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2021 February 2022
Overall Status: Recruiting Completed
Study Start: March 31, 2021
Primary Completion: July 2021 [Anticipated] October 4, 2021 [Actual]
Study Completion: July 2021 [Anticipated] October 4, 2021 [Actual]
First Submitted: April 8, 2021
First Submitted that
Met QC Criteria:
April 8, 2021
First Posted: April 13, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 8, 2021 February 2, 2022
Last Update Posted: April 13 February 3, 2021 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Garmin International
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.
Detailed Description:
Open or close this module Conditions
Conditions: Atrial Fibrillation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 460 [Anticipated] 568 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Atrial fibrillation (AF)
Patients with a known history of AF who are in AF at the time of study screening.
Diagnostic Test: Electrocardiogram
Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.
Normal Sinus Rhythm (SR)
Patients with no known diagnosis of AF or other arrhythmia
Diagnostic Test: Electrocardiogram
Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Specificity of rhythm classification
[ Time Frame: 1 Day ]

Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
2. Sensitivity of rhythm classification
[ Time Frame: 1 Day ]

Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG
Secondary Outcome Measures:
1. Number of ECGs that pass a visual overlay
[ Time Frame: Day 1 ]

Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
2. Difference in R-wave amplitudes between the software and gold standard reference
[ Time Frame: Day 1 ]

Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference
Open or close this module Eligibility
Minimum Age: 22 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Able to read, understand, and provide written informed consent;
  • Willing and able to participate in the study procedures as described in the consent form;
  • Individuals who are 22 years of age and older;
  • Able to communicate effectively with and follow instructions from the study staff;
  • Have a wrist circumference that fits within the device band; and
  • For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening.

Exclusion Criteria:

  • Physical disability that precludes safe and adequate testing;
  • Mental impairment resulting in limited ability to cooperate;
  • Subjects with a pacemaker or implantable cardioverter-defibrillator (ICD);
  • Acute myocardial infarction within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, increases the risk to the subject or renders data uninterpretable;
  • Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis within 90 days of screening;
  • Stroke or transient ischemic attack within 90 days of screening;
  • Subjects taking rhythm control drugs;
  • Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis, or allergic contact dermatitis on both wrists or over electrode attachment sites, including known allergy or sensitivity to silicone bands primarily used in wrist-worn fitness devices;
  • Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or ECG electrodes;
  • A history of abnormal life-threatening rhythms as determined by the Investigator;
  • Significant tremor that prevents subject from being able to hold still;
  • Women who are pregnant at the time of study participation; and
  • Subjects enrolled into the SR population must not have any diagnosis of AF.
Open or close this module Contacts/Locations
Central Contact Person: Travis W Johnson
Telephone: 1-913-440-2624 Ext. 2624
Email: travis.johnson@garmin.com
Central Contact Backup: Liz K Waters
Telephone: 1-913-440-5136 Ext. 5136
Email: Liz.Waters@garmin.com
Locations: United States, Arizona
Hope Research Institute
[Not yet recruiting]
Phoenix, Arizona, United States, 85018
Contact:Contact: Crystal Calzadillas 602-288-4673 michele.aguirre@hriaz.com
Hope Research Institute
Phoenix, Arizona, United States, 85018
United States, District of Columbia
MedStar Washington Hospital Center
[Not yet recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: John A Bonilla 202-877-2336 john.a.bonilla@medstar.net
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Minnesota
HealthEast
[Not yet recruiting]
Saint Paul, Minnesota, United States, 55102
Contact:Contact: Sarah Zwagerman 651-326-4448 sazwagerman@healtheast.org
HealthEast
Saint Paul, Minnesota, United States, 55102
United States, New York
Northwell Health North Shore University Hospital
[Recruiting]
Manhasset, New York, United States, 11030
Contact:Contact: Shannon Kats 516-708-2558 skats@northwell.edu
Northwell Health Lenox Hill Hospital
[Recruiting]
New York, New York, United States, 10075
Contact:Contact: Kristie Coleman 212-434-6500 kcoleman1@northwell.edu
United States, Virginia
MedStar Health Cardiac Electrophysiology at Fairfax
[Not yet recruiting]
Fairfax, Virginia, United States, 22031
Contact:Contact: John A Bonilla 202-877-2336 john.a.bonilla@medstar.net
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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