Status:
ENROLLING_BY_INVITATION
Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation
Lead Sponsor:
University of California, San Francisco
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Brief Summary
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 ris...
Detailed Description
This is a single center, longitudinal, observational cohort study. 3000 subjects are planned to be enrolled. Each subject will be consented, enrolled and assigned to a group based on AF diagnosis (AF ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Life expectancy \< 1 year
- Reversible causes of AF (e.g., post-operative AF, cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
- Pregnant at the time of enrollment
- Unwilling/unable to perform follow-up using digital follow-up
- CKD requiring dialysis
- 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
- Existing Pacemakers and ICDs if not undergoing an ablation
Key Trial Info
Start Date :
September 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2040
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04404465
Start Date
September 15 2020
End Date
September 15 2040
Last Update
July 8 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143