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Clinical Trials/NCT03937089
NCT03937089
Completed
Not Applicable

Analysis of the Endocavitary Electrical Signal and Surface Electrocardiogram to Determine Relevant Features for an Accurate Prediction of Ablation Outcome for Patients in Persistent Atrial Fibrillation

Central Hospital, Nancy, France1 site in 1 country300 target enrollmentMay 24, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Central Hospital, Nancy, France
Enrollment
300
Locations
1
Primary Endpoint
Analysis of the f-waves on ECG
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 24, 2018
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Analysis of the f-waves on ECG

Time Frame: Through study completion, an average of 6 months

Study Sites (1)

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