Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04045067
Acronym
SCAR-AF
Enrollment
212
Registered
2019-08-05
Start date
2019-09-25
Completion date
2023-09-11
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Persistent, Cardiovascular Diseases

Keywords

Ablation, Low voltage areas

Brief 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.

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.

Interventions

PROCEDUREIsolation 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.

PROCEDUREAblation 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.

Sponsors

French Cardiology Society
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the success rate of the proceduresmonth 18Comparison between the 3 study arms of the number of new episodes of symptomatic atrial fibrillation

Secondary

MeasureTime frameDescription
Evaluation of the efficiency of the proceduresDay 1Comparison 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.
Evaluation of the safety of the proceduresDay 1 / month 3 / month 6 / month 12 / month 18Comparison 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026