Analysis of Endocavitary Electrical Signal and Surface Electrocardiogram to Predict Ablation Outcome in Persistent Atrial Fibrillation

NCT ID: NCT03937089

Last Updated: 2019-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-24

Study Completion Date

2018-12-31

Brief Summary

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Background :

Despite recent progress in the management of patients with Atrial Fibrillation (AF), AF remains one of the main risk factor of stroke, heart failure and cardiovascular mortality in the world. AF is the most common cardiac arrhythmia, and its prevalence is expected to grow in the coming years.

Catheter ablation (CA) of AF can be successful in restoring and maintaining Sinus rhythm (SR) in patients with paroxysmal, and persistent AF. Haissaguerre et al. have shown that AF ablation of the heart by isolating the Pulmonary Vein is usually sufficient. However, when ablating persistent AF patients ablating pathological regions in the atria is also required. CA is still a challenging procedure, and reported success rate for persistent AF patients remains relatively low (around 60%). This procedure is associated with risks inherent to any invasive cardiac procedures.

A better identification of good responders would reduce the risks associated with ablation, especially for patients with low odds of favorable outcome, while also increasing the success rate of the procedure. It has been shown in the literature the long-term CA outcome can be predicted non-invasively by atrial fibrillatory wave (f-wave) amplitudes.

Hypothesis :

We assume that a morphological analysis of the f-waves on standard twelve ECG will allow for a better CA outcome prediction.

Objectives :

The aim of this study is to automatically analyse the morphology of the ECG signal before a CA procedure, extract relevant features for an accurate prediction of long-term CA outcome for patients in persistent AF.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients

Patients with persistent AF, who underwent a CA procedure in the Nancy hospital between January 2011 and April 2017, will be included in this retrospective study.

Data collection

Intervention Type OTHER

Data collection from medical file

Interventions

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Data collection

Data collection from medical file

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients for which clinical data, along with the ECG signals before and during the CA procedure are available,
* Patients who underwent a first ablation procedure for persistent AF

Exclusion Criteria

* ECG data is not interpretable
* Patients who underwent a second or umpteenth ablation procedure for persistent AF
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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PSS2018/ASEPAF-SELLAL/YB

Identifier Type: -

Identifier Source: org_study_id

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