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Not yet recruiting NCT06647914

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

Observational Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • A composite clinical point used to evaluate the Atrial Fibrosis Score prognostic capability [Time frame: 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.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06647914 · PNRR-MCNT2-2023-12378472

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗