Atrial FibrillationCSPFANCT07572253
A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation
A study testing CARTO SOUND™ FAM System with Varipulse™ PFA Catheter in people with Atrial Fibrillation, run by China National Center for Cardiovascular Diseases.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CARTO SOUND™ FAM System with Varipulse™ PFA Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- CARTO SOUND™ FAM System with Varipulse™ PFA Catheter
- Keywords
- Pulsed Field Ablation, Pulmonary Vein Isolation, CARTO SOUND FAM, Intracardiac Echocardiography, Feasibility Study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARTO SOUND™ FAM System with Varipulse™ PFA CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: PFA Ablation Group | Experimental | Participants with paroxysmal atrial fibrillation receive pulsed field ablation (PFA) guided by CARTO SOUND™ FAM for pulmonary vein isolation. Receives: Device: CARTO SOUND™ FAM System with Varipulse™ PFA Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the ablation procedure
Secondary outcomes (7)
Incidence of 30-Day Serious Adverse Events (SAEs)
Number of participants experiencing SAEs related to the CARTO SOUND™ FAM or PFA procedure.
Measured: Up to 30 days post-procedure
Total Procedure Time
Total procedure duration, measured in minutes from femoral vein puncture to sheath removal.
Measured: Intraoperative (Day 0)
Mapping Time
The duration required to complete the electroanatomical mapping using CARTO SOUND™ FAM, measured in minutes.
Measured: During the procedure (Day 0)
Total Ablation Time
The cumulative duration of pulsed field ablation (PFA) energy delivery, measured in minutes.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: During the procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention: pulsed field ablation guided by CARTO SOUND™ FAM for pulmonary vein isolation.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Central China Fuwai Hospital of Zhengzhou University, The Affiliated Hospital of Qingdao University
- Responsible party
- Principal investigator, Yan Yao, MD,PhD, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572253
- Sponsor's protocol ID
- 2025-3023
- Acronym
- CSPFA
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on Pulmonary Vein Pulsed Field Ablation Guided by CARTO SOUND™ FAM
- ClinicalTrials.gov ID
- NCT07572253
- Acronym / sponsor ID
- CSPFA / 2025-3023
- Conditions
- Atrial Fibrillation
- Keywords
- Pulsed Field Ablation, Pulmonary Vein Isolation, CARTO SOUND FAM, Intracardiac Echocardiography, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Central China Fuwai Hospital of Zhengzhou University, The Affiliated Hospital of Qingdao University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention: pulsed field ablation guided by CARTO SOUND™ FAM for pulmonary vein isolation.
| Arm | Type | Receives |
|---|---|---|
| Experimental: PFA Ablation Group | Experimental | Device: CARTO SOUND™ FAM System with Varipulse™ PFA CatheterParticipants with paroxysmal atrial fibrillation receive pulsed field ablation (PFA) guided by CARTO SOUND™ FAM for pulmonary vein isolation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARTO SOUND™ FAM System with Varipulse™ PFA CatheterPulsed 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. | Device | Experimental: PFA Ablation Group |
Primary outcome
Acute Procedural Success Composite Endpoint
Time frame: Immediately after the ablation procedure
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.
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CARTO SOUND™ FAM System with Varipulse™ PFA Catheter in people with Atrial Fibrillation, run by China National Center for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Liu (8615215607933, liulei@fuwai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Procedural Success Composite Endpoint (time frame: Immediately after the ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.