Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Gregory Marcus, MD, MAS
Headshot of Gregory Marcus
Gregory Marcus

Description

Summary

VIBRANT-AF seeks to: - Identify clinically relevant predictors of effectiveness and complications of AF ablation procedures in a prospective, US-based, multi-center, real-world longitudinal study - Assess changes in modifiable lifestyle-related exposures influence the effectiveness of AF ablation - Determine incidence and predictors of complications of AF ablation procedures Participants will connect with the Eureka Research Platform and answer a series of surveys and activities over a one-year period. They will be asked about lifestyle habits, recurrence of AFib, hospitalizations, and general feelings and emotions.

Details

Catheter ablation for Atrial Fibrillation is the most commonly performed cardiac electrophysiology procedure. Although now standard of care in professional society guidelines, recommendations favoring the procedure are predominately based on randomized trials or single-center experiences from high-volume institutions staffed by expert operators. Participants enrolled in those randomized trials are healthier than those undergoing the procedure in the "real world," and the actual experiences of patients throughout the US are not represented by those referred to tertiary-referral centers that most frequently publish their retrospective observations. Although administrative databases provide a glimpse into what happens in the real-world, ICD-9, ICD-10, and CPT codes cannot capture specific procedural approaches or patient perspectives. For this reason, this study aims to leverage the Eureka Research Platform, a digital health infrastructure to enable longitudinal follow-up and ascertainment of patient reported outcomes. This is a longitudinal, observational cohort study. 15,000 subjects are planned to be enrolled, and will be followed for a period of one year. Subjects will be asked weekly survey questions on weekly habits, complications, medication usage, and hospitalizations. They will have the option to receive AliveCor Kardia devices for remote ECG monitoring, as well as connect their Apple HealthKit data. Surveys will be conducted via the Eureka mobile app. In conjunction with the Eureka Research Platform, the study will leverage the AF Ablation National Cardiovascular Data Registry (NCDR) run by the American College of Cardiology (ACC). This rapidly growing registry includes comprehensive data regarding patient, procedure, and institution-level characteristics, now includes over 200 institutions around the US, and has already enrolled more than 47,000 patients. However, the registry is limited to data collected during the index procedure visit, without longitudinal follow-up or patient reported outcomes. The study will link the Eureka Research Platform data to NCDR registry data on the index procedure for a subset of participants, allowing for analysis of longitudinal follow-up together with index procedure data.

Keywords

Atrial Fibrillation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Adults age 18 and older
  • Must have a smartphone device (iOS and/or Android) and cell phone number to participate on the mobile app, and will be willing to download the Eureka Research Platform mobile application
  • Must have email address to participate on the web portal (accessible on any web-connected device)
  • Undergone a catheter ablation procedure for atrial fibrillation in the week prior to recruitment, or have an ablation planned for within a week from recruitment

You CAN'T join if...

  • Unable to consent for themselves
  • Unable to read, speak, comprehend English

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Gregory Marcus, MD, MAS
    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
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05504356
Study Type
Observational [Patient Registry]
Participants
Expecting 15000 study participants
Last Updated