NCT04703166 · Tulane University School of Medicine
Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
(TiPP)
What this study is about
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
View original scientific description
To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.
Interventions
DEVICE
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 measures
Atrial Myopathy Progression
Time frame: Based on results from CMR scan at baseline at 12-Months CMR scan
To evaluate changes of atrial myopathy (via the extent of atrial fibrosis, the shape of left atrium \[LA\] and the function of the LA). This will be assessed via CMR scans.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New Orleans, Louisiana
Collaborators
Samsung, Preventice
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations