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OpenTrials
Completed

NCT Number: NCT05343923

Atrial Fibrillation Characterization on Paroxysmal and Persistent Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Analysis of the signals on ECG during sinus rhythm

    Time frame: measurement will be performed at the inclusion point [0 months]

    measuring P-wave maximum value [milivolts]

Secondary outcomes

  1. Analysis of the signals on ECG during sinus rhythm

    Time frame: 1) measurement will be performed at the inclusion point [0 months]

    measuring P-wave duration [miliseconds]

Sponsors and collaborators

Lead sponsor

Felipe Atienza

Other

Registry information

Official study title

Electrophysiological Substrate Characterization of Paroxysmal and Persistent Atrial Fibrillation: PAPER-AF Study

Acronym: PAPER-AF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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