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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05343923
Other study ID # PI20/01618
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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]
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