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Completed

NCT Number: NCT04045067

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isolation of pulmonary veins

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

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.

Primary outcomes

  1. Evaluation of the success rate of the procedures

    Time frame: month 18

    Comparison between the 3 study arms of the number of new episodes of symptomatic atrial fibrillation

Secondary outcomes

  1. Evaluation of the efficiency of the procedures

    Time frame: Day 1

    Comparison between the 3 study arms of the duration of the intervention (in minutes), the duration of fluoroscopy (in minutes), rate of X-ray doses delivered during the procedure (in mGym² (milligray per meter²), the induction of atrial fibrillation at the end of the procedure or not.

  2. Evaluation of the safety of the procedures

    Time frame: Day 1 / month 3 / month 6 / month 12 / month 18

    Comparison between the 3 study arms of the number and type of events regarding the types of procedure: pericardial effusion, pericardial drainage, vascular complication, ischemic stroke, heart failure, acute coronary syndrome, new atrial fibrillation episode, death.

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: SCAR-AF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 5, 2019
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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