Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05504356 |
| Other study ID # |
P0548846 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 27, 2022 |
| Est. completion date |
July 31, 2027 |
Study information
| Verified date |
October 2023 |
| Source |
University of California, San Francisco |
| Contact |
Gregory Marcus, MD, MAS |
| Phone |
?(415) 409-9753? |
| Email |
greg.marcus[@]ucsf.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
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.
