Atrial Fibrillation Characterization on Paroxysmal and Persistent Patients (PAPER-AF)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    50
  • sponsor
    Felipe Atienza
Updated on 13 May 2022
fibrillation
antiarrhythmic drug
anticoagulation therapy

Summary

Background and Hypothesis: Atrial Fibrillation (AF) treatment strategies have limitations. The efficacy of the procedure depends in several factors such as age, AF duration, atrial diameter and atrial electrophysiological behavior, determining what has been termed as atrial substrate. Therefore, the effectiveness of one specific treatment such as the ablation procedure, will be determined by the areas responsible for the maintenance of the fibrillation and its modification and/or elimination. The identification of these areas with a clear description of the arrhythmic substrate is one of the most important factors to determine new biomarkers that explain, at electrophysiological level, the properties of the substrate and therefore, increase the acute efficacy and long-term effectiveness of the treatment.

Description

The main objective of this project is to develop and validate new biomarkers based on a pre-existing methodology for the non-invasive identification of the mechanisms that are responsible for the maintenance of AF. This will be achieved by using a body surface potential mapping recording and using the signal to develop a new algorithm that is able to, from the acquired signals acquired during sinus rhythm, extract relevant features for an accurate prediction of long-term ablation outcome for patients with AF.

Details
Condition Atrial Fibrillation
Clinical Study IdentifierNCT05343923
SponsorFelipe Atienza
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with paroxysmal or persistent AF symptomatic and refractory to at least one antiarrhythmic medication arriving in sinus rhythm to the electrophysiology laboratory
Patients must be able and willing to provide written informed consent to participate in the study
Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi

Exclusion Criteria

Patients with inadequate anticoagulation levels, left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure
Patients with moderate-to-severe mitral regurgitation
Patients with contraindications to systemic anticoagulation with heparin or coumadin
Patients who are or may potentially be pregnant
Current enrollment in another investigational drug or device study
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