Atrial Fibrillation (AF)NCT07023237
3D-Guided Pulsed Field Ablation for Paroxysmal AF
An observational study of Atrial Fibrillation (AF) and Pulsed Field Ablation, run by Beijing Anzhen Hospital.
Trial summary
Atrial fibrillation (AF) is a common arrhythmia, especially in the elderly, and can lead to severe complications like stroke and heart failure. In China, AF affects approximately 20 million adults, and its prevalence is expected to rise due to aging [1, 2]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Pulsed Field Ablation
- What is being tested?
- pulsed field ablation
- Type of treatment
- Surgery or procedure
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 15 Aug 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with paroxysmal atrial fibrillation scheduled for radiofrequency ablation.
Who may be able to join
- Aged 18 years or older, regardless of gender.
- Patients with paroxysmal atrial fibrillation scheduled for catheter ablation.
- Willing and able to comply with all follow-up requirements and agree to participate in this study.
Who cannot join
- Previous left atrial catheter ablation.
- Left ventricular ejection fraction (LVEF) < 35%.
- Left atrial diameter (assessed by echocardiography) > 55 mm.
- Presence of definite thrombus in the left atrium or any other cardiac chamber detected before surgery.
- Patients with New York Heart Association (NYHA) functional class III-IV heart failure.
- Patients with second-degree (Type II) or third-degree atrioventricular block.
Show all 20Show fewer
- Significant congenital heart defects (e.g., atrial septal defect or severe pulmonary vein stenosis, but not including patent foramen ovale).
- Patients with prosthetic heart valves.
- Patients with implanted cardiac pacemakers or implantable cardioverter-defibrillators (ICDs).
- Patients diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
- Patients with known symptomatic carotid artery stenosis before surgery.
- Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Patients with systemic active infections.
- Patients with significant bleeding tendencies or those undergoing hemodialysis for renal failure.
- Patients who have experienced a myocardial infarction or undergone any cardiac intervention/open-heart surgery within the past 3 months.
- Patients who have had a stroke or transient ischemic attack within the past 6 months.
- Patients with significant contraindications to interventional procedures, as determined by the investigator, who are unable to undergo ablation surgery.
- Pregnant or breastfeeding women, or those planning to conceive during the study period.
- Patients who have participated in other drug or medical device clinical trials within the past 3 months.
- Patients whom the investigator deems unsuitable for participation in this clinical trial.
About this study
Official title: Three-Dimensional Guidance for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Study on Efficacy and Safety
Atrial fibrillation (AF) is a common arrhythmia, especially in the elderly, and can lead to severe complications like stroke and heart failure. In China, AF affects approximately 20 million adults, and its prevalence is expected to rise due to aging [1, 2]. Catheter ablation has become a first-line treatment for AF, with pulsed field ablation (PFA) gaining attention due to its tissue selectivity and non-thermal ablation properties [3-8]. PFA uses high-voltage electric fields to create cell membrane perforations, leading to permanent tissue damage and effective arrhythmia treatment [6-8].
Recent studies have shown that PFA is highly effective and safe. For example, the EU-PORIA study reported a 99.96% pulmonary vein isolation (PVI) rate with a 3.6% complication rate [9, 10], while the ADVENT study demonstrated similar efficacy to thermal ablation but with shorter procedure times [12]. However, current PFA systems often lack integration with 3D mapping systems, limiting their application in complex cases and increasing reliance on fluoroscopy [13, 14].
Read more
In China, domestic PFA technology is rapidly evolving, with a focus on expanding indications and integrating 3D techniques [19, 20]. The investigators have conducted preliminary studies on the feasibility and safety of domestic PFA in persistent AF treatment [21]. To further advance PFA, larger-scale clinical studies are needed to optimize procedural workflows and reduce complications.
This study aims to enroll 430 participants through a single-center, single-arm approach. By following up for one year, the investigators will optimize the PFA procedure under 3D guidance to enhance success rates and safety. This will support the clinical promotion of PFA technology and provide valuable data for the development of domestic PFA devices.
- Conditions
- Atrial Fibrillation (AF), Pulsed Field Ablation
- Being tested
- pulsed field ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed field ablationProcedure or surgery
Pulsed electric fields refer to the generation of high-voltage electric fields with pulse widths ranging from milliseconds to microseconds or even nanoseconds. These fields release extremely high energy in a very short time, creating a large number of irreversible micropores in the cell membrane and even intracellular organelles such as the endoplasmic reticulum, mitochondria, and nucleus. This ultimately leads to apoptosis of the diseased cells, achieving the desired therapeutic effect.
By inserting a pulsed ablation catheter into the patient's body and reaching the target lesion, the pulsed energy is delivered to the ablation catheter via a cardiac pulsed field ablation device, thereby achieving the therapeutic goal of pulsed field ablation.
What is being measured
The primary outcome is the main question the study is designed to answer.
12-Month Postoperative Treatment Success Rate
Definition of 12-Month Postoperative Treatment Success: No recurrence of atrial arrhythmias (atrial fibrillation, atrial tachycardia, or unexplained atrial flutter) lasting ≥30 seconds from 3 months to 12 months postoperatively, and no occurrence of any of the following failure modes: immediate procedural failure, repeat ablation failure (more than 1 repeat ablation during the blanking period, or any repeat ablation outside the blanking period), antiarrhythmic drug (AAD) failure (use of new Class I/III AADs for treatment of atrial fibrillation, atrial tachycardia, or unexplained atrial flutter, or increased dosage of previously failed Class I/III AADs), persistent atrial fibrillation/atrial tachycardia/atrial flutter documented by standard 12-lead ECG, or failure of electrical cardioversion.
Calculation: 12-Month Postoperative Treatment Success Rate = (Number of patients with treatment success at 12 months / Total number of patients completing 12-month follow-up) × 100%
Measured: 12 months
Secondary outcomes (2)
Immediate Procedural Success Rate
Definition of Immediate Procedural Success: Achievement of complete pulmonary vein isolation and superior vena cava isolation after ablation.
Calculation: Immediate Procedural Success Rate = (Number of patients with immediate procedural success / Total number of patients undergoing the procedure) × 100%
Measured: immediately after procedure
Success Rate of No Recurrence of Atrial Arrhythmias (≥30 seconds) Without Class I/III AADs from 3 Months to 12 Months Postoperatively
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023237
- Sponsor's protocol ID
- PFA
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Guidance for Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation: A Study on Efficacy and Safety
- ClinicalTrials.gov ID
- NCT07023237
- Acronym / sponsor ID
- PFA
- Conditions
- Atrial Fibrillation (AF), Pulsed Field Ablation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 15 Jun 2025 (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.
Atrial fibrillation (AF) is a common arrhythmia, especially in the elderly, and can lead to severe complications like stroke and heart failure. In China, AF affects approximately 20 million adults, and its prevalence is expected to rise due to aging [1, 2]. Catheter ablation has become a first-line treatment for AF, with pulsed field ablation (PFA) gaining attention due to its tissue selectivity and non-thermal ablation properties [3-8]. PFA uses high-voltage electric fields to create cell membrane perforations, leading to permanent tissue damage and effective arrhythmia treatment [6-8].
Recent studies have shown that PFA is highly effective and safe. For example, the EU-PORIA study reported a 99.96% pulmonary vein isolation (PVI) rate with a 3.6% complication rate [9, 10], while the ADVENT study demonstrated similar efficacy to thermal ablation but with shorter procedure times [12]. However, current PFA systems often lack integration with 3D mapping systems, limiting their application in complex cases and increasing reliance on fluoroscopy [13, 14].
In China, domestic PFA technology is rapidly evolving, with a focus on expanding indications and integrating 3D techniques [19, 20]. The investigators have conducted preliminary studies on the feasibility and safety of domestic PFA in persistent AF treatment [21]. To further advance PFA, larger-scale clinical studies are needed to optimize procedural workflows and reduce complications.
This study aims to enroll 430 participants through a single-center, single-arm approach. By following up for one year, the investigators will optimize the PFA procedure under 3D guidance to enhance success rates and safety. This will support the clinical promotion of PFA technology and provide valuable data for the development of domestic PFA devices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal atrial fibrillation scheduled for radiofrequency ablation.
Key inclusion criteria (3 listed)
- Aged 18 years or older, regardless of gender.
- Patients with paroxysmal atrial fibrillation scheduled for catheter ablation.
- Willing and able to comply with all follow-up requirements and agree to participate in this study.
Key exclusion criteria (20 listed)
- Previous left atrial catheter ablation.
- Left ventricular ejection fraction (LVEF) < 35%.
- Left atrial diameter (assessed by echocardiography) > 55 mm.
- Presence of definite thrombus in the left atrium or any other cardiac chamber detected before surgery.
- Patients with New York Heart Association (NYHA) functional class III-IV heart failure.
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 |
|---|---|---|
| pulsed field ablationPulsed electric fields refer to the generation of high-voltage electric fields with pulse widths ranging from milliseconds to microseconds or even nanoseconds. These fields release extremely high energy in a very short time, creating a large number of irreversible micropores in the cell membrane and even intracellular organelles such as the endoplasmic reticulum, mitochondria, and nucleus. This ultimately leads to apoptosis of the diseased cells, achieving the desired therapeutic effect. By inserting a pulsed ablation catheter into the patient's body and reaching the target lesion, the pulsed energy is delivered to the ablation catheter via a cardiac pulsed field ablation device, thereby achieving the therapeutic goal of pulsed field ablation. | Procedure or surgery | – |
Primary outcome
12-Month Postoperative Treatment Success Rate
Time frame: 12 months
Definition of 12-Month Postoperative Treatment Success: No recurrence of atrial arrhythmias (atrial fibrillation, atrial tachycardia, or unexplained atrial flutter) lasting ≥30 seconds from 3 months to 12 months postoperatively, and no occurrence of any of the following failure modes: immediate procedural failure, repeat ablation failure (more than 1 repeat ablation during the blanking period, or any repeat ablation outside the blanking period), antiarrhythmic drug (AAD) failure (use of new Class I/III AADs for treatment of atrial fibrillation, atrial tachycardia, or unexplained atrial flutter, or increased dosage of previously failed Class I/III AADs), persistent atrial fibrillation/atrial tachycardia/atrial flutter documented by standard 12-lead ECG, or failure of electrical cardioversion. Calculation: 12-Month Postoperative Treatment Success Rate = (Number of patients with treatment success at 12 months / Total number of patients completing 12-month follow-up) × 100%
2 secondary outcomes
Immediate Procedural Success Rate
Time frame: immediately after procedure
Success Rate of No Recurrence of Atrial Arrhythmias (≥30 seconds) Without Class I/III AADs from 3 Months to 12 Months Postoperatively
Time frame: 12 months
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 15 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation (AF)
RecruitingObservational study
BOdygUardian MOnitoriNg for ReCurrencE of AF
Atrial Fibrillation (AF)
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Gastrointestinal Bleeding
Recruiting
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Atrial Fibrillation (AF)
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
RecruitingObservational study
PULSED AF Post-Approval Study
Atrial Fibrillation
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Pulsed Field Ablation, run by Beijing Anzhen Hospital.
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 3 inclusion and 20 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 15 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Month Postoperative Treatment Success Rate (time frame: 12 months). 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 15 Jun 2025.