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

Cardiovascular Diseases Clinical Trial

— SCAR-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045067
• Other study ID #: 2019-02
• Status: Completed
• Start date: September 25, 2019
• Est. completion date: September 11, 2023

Study information

• Verified date: September 2023
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation, Persistent
• Cardiovascular Diseases

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Clinique de l'Infirmerie Protestante de Lyon	Caluire-et-Cuire
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Hôpital Privé Beauregard	Marseille
France	Hôpital Saint-Joseph	Marseille
France	Clinique Ambroise Paré	Neuilly-sur-Seine
France	Hôpital Universitaire Pitié Salpêtrière	Paris
France	Centre Cardiologique du Nord	Saint-Denis
France	Clinique Saint Gatien	Tours

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the success rate of the procedures	Comparison between the 3 study arms of the number of new episodes of symptomatic atrial fibrillation	month 18
Secondary	Evaluation of the efficiency of the procedures	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.	Day 1
Secondary	Evaluation of the safety of the procedures	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.	Day 1 / month 3 / month 6 / month 12 / month 18