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

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · May 21, 2020

Keywords

ClinConnect Summary

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 Group, AF Risk Group and Control Group). All subjects will be given mobile devices (such as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for remote ECG monitoring. Additionally, sleep and activity can be monitored through a smartphone app (on the Eureka Research Platform). All subjects will receive serial blood draws and saliva sample collections to collect serum, pla...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. At least 18 years of age or older
• • 2. English speaking
• • 3. Able to consent
• 4. ANY one of the following criteria:
• • 1. Patients undergoing ablation for AF.
• • 2. 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).
• • 3. A history of newly diagnosed persistent AF with documented normal sinus rhythm within 6 months of enrollment and undergoing cardioversion fot AF.
• 4. 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
• • 5. More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)
• • 6. Patients undergoing EP study or ablation for SVT with no history of AF and not meeting any of the above criteria (a-c).
• Exclusion Criteria:
• • 1. Life expectancy \< 1 year
• • 2. Reversible causes of AF (e.g., post-operative AF, cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
• • 3. Pregnant at the time of enrollment
• • 4. Unwilling/unable to perform follow-up using digital follow-up
• • 5. CKD requiring dialysis
• • 6. 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
• • 7. Patients undergoing active treatment for cancer or diagnosed with cancer requiring treatment in the last 2 years
• • 8. Severe Valvular Disease (eg. Rheumatic Heart Disease, Severe Mitral Valve Regurgitation, severe tricuspid regurgitation, severe aortic stenosis, or valve replacements)
• • 9. History of organ transplant
• • 10. History of any significant congenital heart defect
• • 11. Existing Pacemakers and ICDs if not undergoing an ablation