Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Jeffrey E Olgin, MDEdward P Gerstenfeld, MDMark J Pletcher, MDGregory Marcus, MD
Photo of Jeffrey E Olgin
Jeffrey E Olgin
Photo of Edward P Gerstenfeld
Edward P Gerstenfeld
Photo of Mark J Pletcher
Mark J Pletcher
Photo of Gregory Marcus
Gregory Marcus

Description

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 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 (such as an AliveCor or similar device) 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.

Details

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 or similar device) 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, plasma, whole blood, DNA and RNA in order to observe/identify any changes in blood-borne AF markers. Subjects will also undergo serial imaging in the form of an Echo to observe/identify markers and/or changes in cardiovascular structure and functioning. Evaluations will be taken at baseline and once a year for three years from their baseline visit. Additionally, electronic surveys will be administered periodically (eVisits occurring every 3-6 months) using the mobile app to observe any changes in participant reported symptoms. Any participant who receives an AF ablation as part of clinical care will additionally receive one in-person follow-up three months post-ablation procedure and an electronic survey one month post-ablation procedure to observe changes in symptoms after ablation. Subjects will be followed for at least 3 years. The total duration of the study is expected to be at least 10 years. It is expected that it will take 3-4 years for subject recruitment and at least 3 years for subject follow-up (3 yearly in-person visits), but anticipate the digital follow-up to go beyond that (at least 10 years of digital follow-up)

Keywords

Atrial Fibrillation

Eligibility

You can join if…

Open to people ages 18 years and up

  1. At least 18 years of age or older
  2. English speaking
  3. Able to consent
  4. ANY one of the following criteria:
  5. A history of non-valvular AF or AFL documented on ECG or ambulatory monitoring within 1 year of enrollment
  6. Two or more of the following criteria if no history of AF:
  7. Age > 65 years of age
  8. A diagnosis of hypertension
  9. A diagnosis of diabetes
  10. A diagnosis of sleep apnea
  11. A BMI ≥ 30
  12. Stable HF with preserved or reduced ejection fraction (NYHA Class I, II or III)
  13. CKD not requiring dialysis
  14. More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)
  15. Patients undergoing EP study or ablation for SVT with no history of AF and not meeting any of the above criteria (a-c).

You CAN'T join if...

  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

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientists at UCSF

  • Jeffrey E Olgin, MD
    CLINICAL INTERESTS: Dr. Olgin is a Cardiologist and a Cardiac Electrophysiologist. His main clinical interests include conduction disorders, arrhythmias, catheter ablation, implantable devices—pacemakers and defibrillators, atrial fibrillation, atrial flutter, ventricular tachycardia, sudden death and supraventricular tachycardia.
  • Edward P Gerstenfeld, MD
    Dr Gerstenfeld is the Melvin Scheinman Endowed Professor of Medicine and Chief of the Section of Cardiac Electrophysiology at UCSF.
  • Mark J Pletcher, MD
    As an epidemiologist and a general internal medicine physician, my research is designed to inform clinical decision-making and policy relevant to primary care and prevention.
  • Gregory Marcus, MD
    CLINICAL Dr. Gregory Marcus is a specialist in the treatment of arrhythmias, including mapping and catheter ablation for atrial fibrillation, supraventricular tachycardias and ventricular arrhythmias. He is also an expert in pacemaker, biventricular device and defibrillator implantation. RESEARCH Dr. Marcus is Associate Chief of Cardiology for Research at UCSF Health.

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Atrial Fibrillation fact sheet from the Centers for Disease Control and Prevention website.
ID
NCT04404465
Study Type
Observational
Last Updated