Volunteers to Investigate Best Results for Ablation and Novel Therapies for Atrial Fibrillation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Atrial Fibrillation. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Time to Atrial Fibrillation Recurrence [Срок оценки: 1 year]
Вторичные конечные точки (1)
- Mean Change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score [Срок оценки: 6 months, 1 year]
Критерии участия
Критерии включения
- 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
Критерии исключения
- Unable to consent for themselves
- Unable to read, speak, comprehend English
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of California, San Francisco — San Francisco
Публикации
- 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 Atria PMID 41906612
Идентификаторы
NCT: NCT05504356 · P0548846