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

NCT07572253 | Not Yet Recruiting

• 1 other identifier: 2025-3023
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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, we 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. They 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.

Conditions

Atrial Fibrillation

Keywords

Pulsed Field Ablation; Pulmonary Vein Isolation; CARTO SOUND FAM; Intracardiac Echocardiography; Feasibility Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of 30-Day Serious Adverse Events (SAEs)

  Up to 30 days post-procedure

• Total Procedure Time

  Intraoperative (Day 0)

• Mapping Time

  During the procedure (Day 0)

• Total Ablation Time

  During the procedure (Day 0)

• Fluoroscopy Time

  During the procedure (Day 0)

Study Arms (1)

Experimental: PFA Ablation Group

EXPERIMENTAL

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

Interventions

CARTO SOUND™ FAM System with Varipulse™ PFA Catheter DEVICE

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.

Experimental: PFA Ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Central China Fuwai Hospital of Zhengzhou University: collaborator
• The Affiliated Hospital of Qingdao University: collaborator

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Liu

CONTACT

8615215607933; liulei@fuwai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants receive the same intervention: pulsed field ablation guided by CARTO SOUND™ FAM for pulmonary vein isolation.

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share