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.
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.
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.
Single group
CARTO SOUND™ FAM System with Varipulse™ PFA Catheter
DevicePulsed 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.
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.
Incidence of 30-Day Serious Adverse Events (SAEs)
Number of participants experiencing SAEs related to the CARTO SOUND™ FAM or PFA procedure.
Total Procedure Time
Total procedure duration, measured in minutes from femoral vein puncture to sheath removal.
Mapping Time
The duration required to complete the electroanatomical mapping using CARTO SOUND™ FAM, measured in minutes.
Total Ablation Time
The cumulative duration of pulsed field ablation (PFA) energy delivery, measured in minutes.
Click on the lead sponsor to view all of their trials.
China National Center for Cardiovascular Diseases
Lead sponsor
Central China Fuwai Hospital of Zhengzhou University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
