Paroxysmal Atrial FibrillationSCENA-AFNCT06039722
Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation
A study testing Pulse ablation catheter in people with Paroxysmal Atrial Fibrillation, run by Shenzhen Pulsecare Medical Technology Co., Ltd. at 1 site in China.
Trial summary
This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%. Principle evaluation indexes： 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Pulse ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2022to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subjects must meet all of the following conditions to be enrolled:
- 18 to 80 years of age, gender is not limited
- Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
- Patients who were to undergo catheter ablation of atrial fibrillation
- Those who agreed to participate in this study and voluntarily signed the informed consent form
Who cannot join
- Subjects were excluded if they met one of the following conditions:
- Patients who have had ablation for atrial fibrillation
- Patients with left ventricular ejection fraction (LVEF) <35%.
- Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm
- Preoperative detection of a definite thrombus in the left atrium
- Patients with cardiac function class (NYHA) III-IV
Show all 21Show fewer
- Patients with second-degree (type II) or third-degree atrioventricular block
- Patients with significant congenital heart defects (including atrial septal defect, ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or severe pulmonicvalve, but not including foramen ovale persistens)
- Patients with implanted prosthetic valves or the presence of severe heart valve disease, who are not suitable for ablation for atrial fibrillation
- Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator (ICDs)
- Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive pulmonary disease, or myxoma
- Patients who need to undergo left atrial appendage closure in the same surgery
- Patients found to have atrial flutter preoperatively and judged unsuitable by the investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous origin) or paroxysmal supraventricular tachycardia
- Patients with active systemic infection who are judged unsuitable for interventional therapy by the investigators
- Patients with systemic bleeding tendencies that preclude surgery or patients with renal failure undergoing hemodialysis
- Patients who have had a myocardial infarction or any interventional/open heart surgery (except coronary angiography) within 3 months
- Patients who have had a stroke (except asymptomatic stroke) or transient ischemic attack within 3 months
- Patients with significant contraindications to interventional procedures or with an expected survival of <1 year who are judged by the investigator to be incapable of undergoing ablative procedures
- Females who are pregnant or breastfeeding or who are planning to have children during the study period
- Patients who have participated in a clinical trial of another drug or medical device within 3 months
- Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）
Guangzhou, Guangdong, 510120
About this study
Official title: Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.
This study is expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%.
Principle evaluation indexes：
Read more
- Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
- Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
- Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.
Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Secondary evaluation indexes：
- The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
- Device performance evaluation;
Safety evaluation indexes：
- The occurrence of death, stroke, or transient ischemic attack;
- The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc;
- Clinically significant vital signs and related examinations;
- The occurrence of other adverse events and serious adverse events during the trial period.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Pulse ablation catheter
- Keywords
- Pulse Field Ablation Catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse ablation catheterDevice
Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Each subject underwent pulse ablation catheter ablation Receives: Device: Pulse ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate success rate of surgery
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
Measured: After surgery 20 minutes later
Treatment success rate
Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.
Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Measured: Between 3 months and 12 months after ablation
Secondary outcomes (2)
numer of cases of the the occurrence of hospitalization or emergency treatment
The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
Measured: Between 0 months and 12 months after ablation
Device performance evaluation
Device defects of the clinical trial equipment
Measured: surgery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start3 Nov 2022
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039722
- Sponsor's protocol ID
- PMTCT2022001
- Acronym
- SCENA-AF
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xie S, Lai H, Jia F, Zhang Z, Wang Y, Yin Y, Chen Q, Huang H, Liu Q, He J, Yang P, Wang J. High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial. Circ Arrhythm Electrophysiol. 2026 Feb;19(2):e014236. doi: 10.1161/CIRCEP.125.014236. Epub 2026 Feb 4.
PubMed 41636062
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT06039722
- Acronym / sponsor ID
- SCENA-AF / PMTCT2022001
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Pulse Field Ablation Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Shenzhen Pulsecare Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 15 Sep 2023 (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 expected to include 166 subjects and Conducted at 11 research centers；The expected 12 month treatment success rate of using research instruments is 65%.
Principle evaluation indexes：
- Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
- Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
- Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.
Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
Secondary evaluation indexes：
- The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
- Device performance evaluation;
Safety evaluation indexes：
- The occurrence of death, stroke, or transient ischemic attack;
- The occurrence of surgical related complications, such as vascular puncture complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc;
- Clinically significant vital signs and related examinations;
- The occurrence of other adverse events and serious adverse events during the trial period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Pulse ablation catheterEach subject underwent pulse ablation catheter ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 80 years of age, gender is not limited
- Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG
- Patients who were to undergo catheter ablation of atrial fibrillation
- Those who agreed to participate in this study and voluntarily signed the informed consent form
Key exclusion criteria (21 listed)
- Patients who have had ablation for atrial fibrillation
- Patients with left ventricular ejection fraction (LVEF) <35%.
- Patients with an anteroposterior diameter of the left atrium (echocardiography) >50 mm
- Preoperative detection of a definite thrombus in the left atrium
- Patients with cardiac function class (NYHA) III-IV
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 |
|---|---|---|
| Pulse ablation catheterPulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential | Device | experimental group |
Primary outcome
Immediate success rate of surgery
Time frame: After surgery 20 minutes later
Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation. Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
Treatment success rate
Time frame: Between 3 months and 12 months after ablation
Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs. Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
2 secondary outcomes
numer of cases of the the occurrence of hospitalization or emergency treatment
Time frame: Between 0 months and 12 months after ablation
Device performance evaluation
Time frame: surgery period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Derived from this study: PubMed 41636062Xie S, Lai H, Jia F, Zhang Z, Wang Y, Yin Y, Chen Q, Huang H, Liu Q, He J, Yang P, Wang J. High-Repetition-Frequency Nanosecond Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: 12-Month Outcomes From the SCENA-AF Trial. Circ Arrhythm Electrophysiol. 2026 Feb;19(2):e014236. doi: 10.1161/CIRCEP.125.014236. Epub 2026 Feb 4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulse ablation catheter in people with Paroxysmal Atrial Fibrillation, run by Shenzhen Pulsecare Medical Technology Co., Ltd. at 1 site in China.
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 5 inclusion and 21 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: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immediate success rate of surgery (time frame: After surgery 20 minutes later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039722, which also lists 1 linked publication.
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 19 Jun 2025.