Atrial FibrillationDigital healthHeart and circulationDevice
What this study is
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
What's being tested
- Samsung Galaxy Watch Active2
Intervention · DEVICE
The Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.
Study details
- Official title
- Tulane iPredict, Prevent (TiPP) Study
- Sponsor
- Tulane University School of Medicine
- Conditions
- Atrial Fibrillation
- Enrolling
- 98 people
- Starts
- 2025-04-08
- Est. completion
- 2027-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 79 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openTulane University School of Medicine
New Orleans, Louisiana, United States
- Quintrele Jones, MPH · Contact504-988-3063qjones1@tulane.edu
- Chris Wang, MS · Contact504-988-3065hwang37@tulane.edu
- Nassir F Marrouche, MD · Principal investigator
Recruiting
Study team
Sponsor
Tulane University School of Medicine
Study ID 2849006
Principal investigator
Nassir F Marrouche, MD
Tulane University School of Medicine
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.