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

NCT03937089 | Completed

• 1 other identifier: PSS2018/ASEPAF-SELLAL/YB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Analysis of the f-waves on ECG

  Through study completion, an average of 6 months

Study Arms (1)

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.

Other: Data collection

Interventions

Data collection OTHER

Data collection from medical file

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: May 3, 2019
• Study Start: May 24, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 3, 2019

Record last verified: 2018-10

Locations

FR (1)