Recruiting

Atrial Myopathy

Sponsor:

Tulane University School of Medicine

Code:

NCT04703166

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Samsung Galaxy Watch Active2

Study Details

Brief summary:

To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.

Conditions

Atrial Fibrillation

Study ID

NCT04703166

Start date

Apr 8, 2025

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants must meet the following criteria to be enrolled in the trial:

  • Participants with atrial fibrillation aged 18 to 79 years old, or
  • Participants aged 40 to 79 years old, at moderate or high risk for CVD as defined by the 10-year risk Atherosclerotic Cardiovascular Disease (ASCVD), a validated risk calculation tool.
  • Participants who have access to internet/e-mail in their homes.
  • Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
  • Participants who are able and willing to return to the study clinic one-year following their baseline CMR for a follow-up appointment and 12-month CMR.
  • Participants who are able to read, understand, and sign the consent form.

Exclusion Criteria:

Participants will be excluded from enrollment if any of the following criteria are present:

  • Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.).
  • Participants weighing >300 lbs. (MRI quality decreases as BMI increases).
  • Participants with renal insufficiency (Glomerular Filtration Rate (GFR) <30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease.
  • Women who are pregnant at the time of enrollment/consent. (Should a participant become pregnant during the course of the study, no CMR will be performed until 10 days, postpartum).
  • Participants who do not have access to the internet/e-mail.
  • Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
  • Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
  • Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR.
  • Participants with cognitive impairments who are unable to give informed consent.

Study Design

Enrollment

360 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with Atrial Fibrillation or have Moderate-high risk factors for Atrial Fibrillation

Participants who have atrial fibrillation or have moderate to high-risk factors for the development of atrial fibrillation as verified by the Atherosclerotic CardioVascular Disease (ASCVD) risk calculation tool.

Participants will be provided with a Samsung Galaxy Watch to wear daily and will also be asked to wear an ECG patch for 30-days at baseline, 6, 9 and 12 months.

A Cardiac MRI (CMR) will be taken at baseline and at 12 months.

Interventions

Samsung Galaxy Watch Active2

The Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.

Primary outcome measure

  • Atrial Myopathy Progression [ Time Frame: Based on results from CMR scan at baseline at 12-Months CMR scan ]

Central Contacts and Locations

Central contacts

Quintrele Jones, MPH

504-988-3063qjones1@tulane.edu

Chris Wang, MS

504-988-3065hwang37@tulane.edu

Locations

Tulane University School of Medicine

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Quintrele Jones, MPH

504-988-3063qjones1@tulane.edu

Chris Wang, MS

504-988-3065hwang37@tulane.edu

Principal Investigator:

Nassir F Marrouche, MD

More Information

Sponsor

Tulane University School of Medicine

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Atrial Fibrillation
  • Atrial Myopathy
  • Cardiovascular Risk Factors
  • Heart Murmurs
  • Arrhythmias
  • Cardiac Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University School of Medicine on 2026-05-19.