NCT04404465Enrolling by invitation

Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation

Source: ClinicalTrials.gov · Last updated 15 Jul 2026

Brief summary (registry, in English)

Atrial fibrillation (also known as AFib or AF) is the most common abnormal heart rhythm and results in an irregular beating of the heart. Currently, there is no way of identifying patients at most risk for the development or progression of AFib or those that will best respond to treatment. The purpose of this study is to improve our understanding of AFib and to find new ways of identifying those patients most at risk for developing AFib, have progressive AFib or be less responsive to treatment. For this reason, the investigators are studying imaging, blood, and digital markers that may contribute to AFib Subjects will receive mobile devices (uch as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for remote electrocardiographic (ECG) monitoring. Additionally, subjects will use features using a smartphone research app (on the Eureka Research Platform) to monitor other important things such as activity, sleep, heart rate and others as they are developed. All subjects will receive serial blood draws and saliva sample collections once a year. Subjects will also undergo annual imaging in the form of an echocardiogram (Echo). Evaluations will be taken at baseline and once a year for three years from the baseline visit. Additionally, electronic surveys will be administered periodically (eVisits occurring every 3-6 months) using the mobile app.

Status (registry): Enrolling by invitation
Study type: Observational
Enrollment: 3000 (estimated)
First submitted: 15 May 2020
Start date: Sept 2020
Primary completion date: Sept 2030
Lead sponsor: University of California, San Francisco
Diseases: Atrial fibrillation
NCT number: NCT04404465

What you commit to

Study type: Observational
Planned participants: 3000
From Sept 2020 to the primary completion date, Sept 2030
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

Reversible causes of AF (e.g., post-operative AF, cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
Patients undergoing active treatment for cancer or diagnosed with cancer requiring treatment in the last 2 years
Severe Valvular Disease (eg. Rheumatic Heart Disease, Severe Mitral Valve Regurgitation, severe tricuspid regurgitation, severe aortic stenosis, or valve replacements)
History of organ transplant
History of any significant congenital heart defect

Other

Life expectancy \< 1 year
Pregnant at the time of enrollment
Unwilling/unable to perform follow-up using digital follow-up
CKD requiring dialysis
Existing Pacemakers and ICDs if not undergoing an ablation

Who the study is looking for

At least 18 years of age or older
English speaking
Able to consent
ANY one of the following criteria:
- Patients undergoing ablation for AF.
- A history of non-valvular AF or AFL (not due to a reversible cause) documented on ECG or ambulatory monitoring within 1 year of enrollment and not on chronic anti-arrhythmic drugs (AAD).
- A history of newly diagnosed persistent AF with documented normal sinus rhythm within 6 months of enrollment and undergoing cardioversion fot AF.
- Two or more of the following criteria if no history of AF:
- Age \> 65 years of age
- A diagnosis of hypertension
- A diagnosis of diabetes
- A diagnosis of sleep apnea
- A BMI ≥ 30
- Stable HF with preserved or reduced ejection fraction (NYHA Class I, II or III)
- CKD not requiring dialysis
- More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)
- Patients undergoing EP study or ablation for SVT with no history of AF and not meeting any of the above criteria (a-c).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of California San Francisco Coordinator of this site? Confirm its status	San Francisco	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.