Atrial Fibrillation Characterization on Paroxysmal and Persistent Patients

Atrial Fibrillation Clinical Trial

— PAPER-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343923
• Other study ID #: PI20/01618
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Felipe Atienza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the signals on ECG during sinus rhythm	measuring P-wave maximum value [milivolts]	measurement will be performed at the inclusion point [0 months]
Secondary	Analysis of the signals on ECG during sinus rhythm	measuring P-wave duration [miliseconds]	1) measurement will be performed at the inclusion point [0 months]