Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation

NCT ID: NCT04045067

Last Updated: 2023-09-13

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

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2023-09-11

Brief Summary

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This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

Detailed Description

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Radiofrequency ablation has become standard practice in the approach strategy for the symptomatic treatment of atrial fibrillation. The interest of substrate ablation, completing the isolation of the pulmonary veins is controversial. The usual technique for the ablation of recurrent atrial fibrillation is primarily a disconnection of the pulmonary veins, which can be accomplished by isolating the veins one by one or two by two. The isolation of the pulmonary veins is followed most often by a defragmentation of the atrium (ablation of the substrate). The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. This strategy requires extensive ablation of the left atrium, with a long procedure time and repeated many radiofrequency shots. On the one hand there is a risk of complication related to the duration of intervention, but also in the longer term of occurrence of flutter scar. In addition to pulmonary vein isolation, the goal is to identify patients with sinus rhythm atrial arrhythmogenic substrate. Once the sinus rhythm has been restored by electrical cardioversion or spontaneously, a voltage map is carried out to identify the most abnormal (low voltage) areas, and intra-atrial fragmented potentials are identified, either spontaneously or spontaneously by the extra-stimulus method. Ablation of these abnormal areas may lead to better long-term results, limiting prolonged radiofrequency shots and complications associated with longer procedure times.

Conditions

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Cardiovascular Diseases Atrial Fibrillation, Persistent

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

A group of patients who have pulmonary vein isolation alone, without low-voltage areas identified.

Isolation of pulmonary veins

Intervention Type PROCEDURE

Low voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins.

Group 2

A group of patients who have pulmonary veins isolation alone, with low-voltage areas identified but the complementary defragmentation will not be carried out.

Isolation of pulmonary veins

Intervention Type PROCEDURE

Low voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins.

Group 3

A group of patients who have pulmonary veins isolation, with low-voltage areas identified and the complementary defragmentation will be carried out.

Isolation of pulmonary veins

Intervention Type PROCEDURE

Low voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins.

Ablation by radiofrequency of low-voltage areas

Intervention Type PROCEDURE

The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation.

Interventions

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Isolation of pulmonary veins

Low voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins.

Intervention Type PROCEDURE

Ablation by radiofrequency of low-voltage areas

The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with persistent atrial fibrillation ablation, no specific indication restrictions or equipment used and regardless of the outcome of the procedure
* Patients participating in a biomedical research can participate in this study.

Exclusion Criteria

* Pregnant or lactating women can not participate in this study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Cardiology Society

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine LEPILLIER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Cardiologique du Nord

Locations

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Centre Hospitalier Universitaire d'Angers

Angers, , France

Site Status

Clinique de l'Infirmerie Protestante de Lyon

Caluire-et-Cuire, , France

Site Status

Centre Hospitalier Saint Joseph Saint Luc

Lyon, , France

Site Status

Hôpital Saint-Joseph

Marseille, , France

Site Status

Hôpital Privé Beauregard

Marseille, , France

Site Status

Clinique Ambroise Paré

Neuilly-sur-Seine, , France

Site Status

Hôpital Universitaire Pitié Salpêtrière

Paris, , France

Site Status

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status

Clinique Saint Gatien

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2019-02

Identifier Type: -

Identifier Source: org_study_id

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