Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation (SCAR-AF)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Atrial Fibrillation, Persistent
• Intervention / Treatment: Procedure: Isolation of pulmonary veins; Procedure: Ablation by radiofrequency of low-voltage areas

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • Centre Hospitalier Universitaire d'Angers
  • Caluire-et-Cuire, France, 69300
    • Clinique de l'Infirmerie Protestante de Lyon
  • Lyon, France, 69007
    • Centre Hospitalier Saint Joseph Saint Luc
  • Marseille, France, 13008
    • Hôpital Saint-Joseph
  • Marseille, France, 13012
    • Hôpital Privé Beauregard
  • Neuilly-sur-Seine, France, 92200
    • Clinique Ambroise Paré
  • Paris, France, 75013
    • Hôpital Universitaire Pitié Salpêtrière
  • Saint-Denis, France, 93200
    • Centre Cardiologique du Nord
  • Tours, France, 37000
    • Clinique Saint Gatien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients included in this protocol will be recruited by the centers that practice the procedure of ablation of persistent atrial fibrillation, by transcutaneous vein and trans-septal catheterization. Participation in this prospective observational study has been proposed to all centers practicing this procedure in France, regardless of the technique used. Inclusion in the study will be systematically offered to each patient who will benefit from this technique.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; A group of patients who have pulmonary vein isolation alone, without low-voltage areas identified.	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.
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.	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.
Group 3; A group of patients who have pulmonary veins isolation, with low-voltage areas identified and the complementary defragmentation will be carried out.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: French Cardiology Society
• Investigators: Principal Investigator: Antoine LEPILLIER, MD, Centre Cardiologique du Nord

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ablation; Low voltage areas
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiovascular Diseases; Atrial Fibrillation
• Other Study ID Numbers: 2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No