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

An Exploratory Study on Pulmonary Vein Pulsed Field Ablation Guided by CARTO SOUND™ FAM

This study is being done to see if a new method for treating a heart rhythm problem called paroxysmal atrial fibrillation (AFib) is safe and works well. AFib causes the upper chambers of the heart (the atria) to beat irregularly, which can lead to symptoms like palpitations, shortness of breath, and tiredness. The usual treatment for AFib when medicines do not help is a procedure called catheter ablation. This procedure uses heat or cold to create small scars in the heart to block abnormal electrical signals. This study uses a newer energy source called pulsed field ablation (PFA), which may be safer for the surrounding tissues (like the esophagus and nerves) because it mainly affects heart cells. Another special part of this study is how doctors build a 3D picture of the left atrium - the part of the heart where AFib starts. Instead of the standard method, the investigators will use a technology called CARTO SOUND™ FAM. This combines heart ultrasound (ICE) with a mapping system to quickly create an accurate 3D model of the left atrium without needing a CT scan or extra injections of dye. The main questions are: Can the doctor successfully isolate all four pulmonary veins (the areas where AFib often starts) using only the study devices (CARTO SOUND™ FAM and PFA)? What are the side effects and safety of this new combination within 30 days after the procedure? About 70 adults aged 18 to 80 with paroxysmal AFib will take part. Participants will have one ablation procedure and will be followed for 1 month after the procedure. The study will measure how long the procedure takes, how much X-ray is used, how well the catheter touches the heart tissue, and any serious medical events. This is an early (feasibility) study to gather information for future, larger studies. It is sponsored by Fuwai Hospital, Chinese Academy of Medical Sciences, and will be done in three hospitals in China.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: CARTO SOUND™ FAM System with Varipulse™ PFA Catheter

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Liu; Phone Number: 8615215607933; Email: liulei@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: PFA Ablation Group; Participants with paroxysmal atrial fibrillation receive pulsed field ablation (PFA) guided by CARTO SOUND™ FAM for pulmonary vein isolation.	Device: CARTO SOUND™ FAM System with Varipulse™ PFA Catheter; Pulsed field ablation is delivered via the Varipulse™ catheter to isolate pulmonary veins, guided by the CARTO SOUND™ FAM system which uses intracardiac echocardiography to reconstruct a 3D model of the left atrium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Procedural Success Composite Endpoint	The composite endpoint defined as meeting all of the following criteria: (1) successful construction of left atrial model using the study catheter; (2) electrical isolation of all target pulmonary veins (entry block confirmed, exit block as needed); (3) completion of entire ablation using only study devices, without cross-over to other ablation tools.	Immediately after the ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 30-Day Serious Adverse Events (SAEs)	Number of participants experiencing SAEs related to the CARTO SOUND™ FAM or PFA procedure.	Up to 30 days post-procedure
Total Procedure Time	Total procedure duration, measured in minutes from femoral vein puncture to sheath removal.	Intraoperative (Day 0)
Mapping Time	The duration required to complete the electroanatomical mapping using CARTO SOUND™ FAM, measured in minutes.	During the procedure (Day 0)
Total Ablation Time	The cumulative duration of pulsed field ablation (PFA) energy delivery, measured in minutes.	During the procedure (Day 0)
Fluoroscopy Time	The duration of fluoroscopy exposure, including both the total fluoroscopy time and the specific fluoroscopy time during the mapping phase, measured in minutes.	During the procedure (Day 0)
Catheter Contact Quality Assessed by ICE	The quality of contact between the ablation catheter and the cardiac tissue, as assessed by Intracardiac Echocardiography (ICE).	During the procedure (Day 0)
Percentage of Positive Tissue Proximity Indicator (TPI) Sites	The percentage of ablation sites showing positive Tissue Proximity Indicator (TPI) signals out of the total number of ablation sites.	During the procedure (Day 0)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: The Affiliated Hospital of Qingdao University; Central China Fuwai Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility Study; Pulmonary Vein Isolation; Pulsed Field Ablation; Intracardiac Echocardiography; CARTO SOUND FAM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: 2025-3023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study did not obtain informed consent from participants for sharing individual participant data (IPD) with external researchers. Additionally, the data are owned by Fuwai Hospital and are subject to institutional confidentiality policies.

Drug and device information, study documents

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