A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CARTO SOUND™ FAM System with Varipulse™ PFA Catheter.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Exploratory Study on Pulmonary Vein Pulsed Field Ablation Guided by CARTO SOUND™ FAM
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Acute Procedural Success Composite Endpoint [Time frame: Immediately after the ablation procedure]
Secondary outcome measures (7)
- Incidence of 30-Day Serious Adverse Events (SAEs) [Time frame: Up to 30 days post-procedure]
- Total Procedure Time [Time frame: Intraoperative (Day 0)]
- Mapping Time [Time frame: During the procedure (Day 0)]
- Total Ablation Time [Time frame: During the procedure (Day 0)]
- Fluoroscopy Time [Time frame: During the procedure (Day 0)]
- Catheter Contact Quality Assessed by ICE [Time frame: During the procedure (Day 0)]
- Percentage of Positive Tissue Proximity Indicator (TPI) Sites [Time frame: During the procedure (Day 0)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07572253 · 2025-3023