跳至主要内容
临床试验/NCT06647914
NCT06647914尚未招募不适用

Predicting Disease Progression in Atrial Fibrillation: A Multiparametric Approach for Prognostic Marker Identification and Personalized Patient Management

IRCCS Policlinico S. Donato0 个研究点目标入组 322 人开始时间: 2025年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
322
主要终点
A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability

研究概览

简要总结

This project leverages artificial intelligence (AI) to decipher Atrial Fibrillation (AF) progression and optimize treatment strategies. By recruiting a diverse cohort of 322 AF patients, we will gather a robust multiparametric dataset including clinical, genetic, electrocardiographic, and echocardiographic data. Harnessing AI, we will extract and correlate hidden components within ECG-obtained P-wave data and echocardiographic studies with atrial fibrosis, culminating in an atrial fibrosis score (AFS). The AFS will non-invasively predict fibrosis extent and AF clinical progression, including metrics like rehospitalization, cardiac morbidity, and mortality. Ultimately, this endeavor aims to improve AF patient management, significantly reducing healthcare costs, and enhancing patient quality of life.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of paroxysmal or persistent atrial fibrillation
  • Clinical indication for Atrial Fibrosis (AF) ablation according to the 2020 ESC Guidelines

排除标准

  • Age below 18 years old
  • Refusal to sign consent
  • Noncompliance with the study protocol

结局指标

主要结局

A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability

时间窗: Partecipants will be assessed at the baseline and at 6 months and 12 months time points. The AFS Prediction Model Testing will start at 9 months after the beginning of the patients enrollment.

The clinical endpoint will be composed by rehospitalization, cardiac morbidity and total mortality data

次要结局

未报告次要终点

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Sponsor

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