A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation

Background and Rationale Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. While pulsed field ablation (PFA) offers a non-thermal, tissue-selective energy source that minimizes collateral damage to adjacent structures (such as the esophagus and phrenic nerve), its efficacy heavily relies on the precise anatomical positioning of the ablation catheter within the complex left atrial (LA) anatomy. Current LA reconstruction methods have limitations: conventional fast anatomical mapping (FAM) requires extensive catheter manipulation, and CT/MRI integration exposes patients to radiation, contrast agents, and additional costs.

The CARTO SOUND™ FAM system addresses these challenges by integrating intracardiac echocardiography (ICE) with a three-dimensional mapping platform. Utilizing an artificial intelligence algorithm, it generates a precise 3D LA model directly from 2D ICE frames acquired from the right atrium and right ventricular outflow tract. This approach aims to reduce LA mapping time while improving the anatomical definition of critical structures, such as the ridge between the left atrial appendage and the pulmonary veins.

Procedural Workflow and Intervention Details This prospective, multicenter study is designed to evaluate the clinical feasibility and acute procedural workflow of combining the CARTO SOUND™ FAM system with PFA. During the procedure, following a transseptal puncture, the CARTO SOUND™ FAM system utilizing an ICE catheter will be deployed to efficiently reconstruct a detailed 3D model of the left atrium and pulmonary veins without crossing the septum with the mapping catheter initially.

Guided by this real-time ultrasound-derived 3D anatomical model, operators will navigate the Varipulse™ PFA catheter to deliver pulsed-field energy for the electrical isolation of target pulmonary veins. The VIZIGO™ steerable sheath may be adjunctive utilized to optimize catheter stability and positioning. Post-ablation, patients will undergo standard clinical management and will be followed for 30 days with continuous monitoring (including 12-lead ECG, 24-hour Holter, and echocardiography) to assess both acute electrophysiological success and short-term procedural safety.

Inclusion criteria

• Diagnosis of paroxysmal atrial fibrillation with an indication for catheter ablation.
• Willing and able to provide written informed consent.
• Age between 18 and 80 years (inclusive).
• Able and willing to comply with all pre-procedure, post-procedure, and follow-up visits and assessments.

Exclusion criteria

• Valvular atrial fibrillation, untreated or uncontrolled thyroid disease, acute coronary syndrome, or atrial fibrillation secondary to cardiomyopathy.
• Any contraindication to catheter ablation (e.g., left atrial thrombus, coagulopathy preventing anticoagulation, severe hepatic/renal dysfunction, psychiatric illness).
• Pregnancy or breastfeeding.
• Malignancy, cachexia, severe ascites, body mass index (BMI) > 40 kg/m², or severe sleep apnea syndrome.
• Participation in another clinical study.
• Any other condition that the investigator considers inappropriate for study participation.
• Contraindication to any study device as specified in the respective instructions for use (IFU).