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| Name | Class |
|---|---|
| American College of Cardiology | OTHER |
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VIBRANT-AF seeks to:
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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Atrial Fibrillation Recurrence | Time to atrial fibrillation, after employing a 3-month blanking period. Atrial Fibrillation Recurrence includes patient-reported symptoms of AF or Kardia-based ECG evidence of AF. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score | Atrial Fibrillation Effect on Quality-of-Life will be measured using the AFEQT, the score ranges from 0 to 100, with higher scores indicating better quality of life | 6 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a diagnosis of AF (i.e. new onset AF, paroxysmal AF, persistent AF, Permanent AF), who have recently or will imminently be undergoing AF ablation. Subjects will be at least 18 years of age or older, and be English-speakers, as well as adhere to the inclusion criteria pertaining to access to the Eureka mobile app (owning a smartphone device and cell phone number, email address)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bella Peña, BA | Contact | 415-502-3053 | bella.pena@ucsf.edu | |
| Hannah Oo, BS | Contact | 415-476-4999 | hannah.oo@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Marcus, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | Recruiting | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41906612 | Derived | Elias A, Holtzman JN, Djomaleu ML, Freeman JV, Natale A, Hsu JC, Tzou WS, Garg L, Dukes JW, Cooper DH, Gionfriddo W, Whitman IR, Isakadze N, Spragg DD, Satti DI, Rosenthal DG, Riles EM, Hills MT, McCall D, Montenegro GC, Oo HH, Lowe DA, Gerstenfeld EP, Moss JD, Dewland TA, Hsia HH, Lee RJ, Tseng ZH, Vedantham V, Marcus GM. Feasibility of Self-Reported Surveillance After Catheter Ablation for Atrial Fibrillation Using A Mobile Application. JACC Adv. 2026 Mar;5(3):102625. doi: 10.1016/j.jacadv.2026.102625. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |