Rotor Modulation Ablation for the Treatment of Persistent Atrial Fibrillation
NCT Number: NCT06539819
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Persistent Atrial Fibrillation
Interventions: PROCEDURE: Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R&B group)|PROCEDURE: Electrical Posterior Box Isolation group (BO group)
Sponsor: Zhujiang Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12

Summary:
For Persistent atrial fibrillation (PeAF), the therapeutic effect of catheter ablation needs to be further improved. 3.Circumferential pulmonary vein isolation (CPVI) is the cornerstone of catheter ablation of AF, and additional ablation methods such as linear ablation or fragmentation potential ablation plus CPVI have been demonstrated to improve the treatment effect of PeAF, but there is still a large gap with the ideal ablation treatment effect.Recent studies have shown that the "rotor" is an important mechanism for the maintenance of PeAF, and related studies have shown that rotor modulation ablation may further improve the success rate of catheter ablation for PeAF. However, on the one hand, there is a lack of effective mapping catheter tool for rotor mapping, and on the other hand, the reproducibility of some related studies still needs to be further confirmed, and further clinical studies are needed to explore whether rotor modulation ablation can improve the success rate of catheter ablation for PeAF. The EnSite™ LiveView dynamic mapping system, combined with the HD Grid mapping catheter, provides a effective mapping tool for clinical surgeons. In the early clinical practice, we successfully completed the rotor mapping ablation using the mapping system, and there was no complication during the operation, which was safe and reliable, and achieved good intraoperative and postoperative results. We intend to conduct this clinical study to explore whether rotor ablation combined with BOX ablation can further improve the efficacy of PeAF compared with BOX ablation alone, and provide guidance for catheter ablation treatment of PeAF. This is a single-center, randomized, parallel-controlled, single-blind clinical trial, and we plan to enroll 360 subjects randomized into Electrical Posterior Box Isolation and Rotor Modulation Ablation group (R\&B group) and Electrical Posterior Box Isolation group (BO group), The corresponding surgery was performed according to the group, and the postoperative follow-up was 12 months, and the main observation endpoint was the remission rate of atrial fibrillation one year after surgery.

Primary Outcome Measures: The rate of freedom from AF within one year after surgery, The rate of freedom from AF within one year after surgery, 1, 3, 6, 12 months after surgery
Secondary Outcome Measures: Incidence of other atrial arrhythmias within one year after surgery, Incidence of other atrial arrhythmias within one year after surgery, 1, 3, 6, 12 months after surgery|Cardiac function, Cardiac function was valued by left ventricular ejection fraction measured by transthoracic echocardiography, 12 months after surgery|Incidence of thrombosis-related events, Incidence of thrombosis-related events, 12 months after surgery|Serious complications associated with ablation procedure, Serious complications associated with ablation procedure, 12 months after surgery