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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Data collection

• Registration Number: NCT03937089
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-24
• Status Verified: 2018-10
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-05-02
• Last Update Submitted: 2019-05-02
• Study First Posted: 2019-05-03
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Data collection	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.

Primary Outcome Measures

Name	Time	Method
Analysis of the f-waves on ECG	Through study completion, an average of 6 months

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France