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Paroxysmal Atrial FibrillationNCT07865221

Pulsed Field Ablation for Paroxysmal Atrial Fibrillation: Clinical Efficacy and Left Atrial Function Protection

A study testing Novel Pulsed Field Ablation System and Radiofrequency Ablation Catheter in people with Paroxysmal Atrial Fibrillation and Pulsed Field Ablation, run by Tianjin Medical University General Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective clinical study aiming to evaluate the clinical efficacy and safety of a novel domestic pulsed field ablation (PFA) system in the treatment of paroxysmal atrial fibrillation (PAF), and to specifically assess its protective effect on left atrial function. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Novel Pulsed Field Ablation System and Radiofrequency Ablation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteChina
Study dates
Oct 2026to Oct 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >= 18 years.
  • Symptomatic paroxysmal atrial fibrillation (AF duration < 7 days).
  • Ineffective treatment with one or more antiarrhythmic drugs (e.g., propafenone, sotalol, amiodarone).
  • Discontinued antiarrhythmic drugs for at least 5 half-lives before the procedure.
  • Willing to receive PFA treatment and postoperative follow-up, and able to sign informed consent.

Who cannot join

  • Previous radiofrequency catheter ablation (RFCA) for atrial fibrillation.
  • Presence of a cardiac pacemaker or post-left atrial appendage closure.
  • Thrombocytopenia (PLT < 80×10^9/L) or contraindications to anticoagulation (e.g., warfarin, heparin, direct factor Xa inhibitors, direct thrombin inhibitors).
  • Left atrial anterior-posterior diameter > 55 mm (by transthoracic echocardiography, parasternal long-axis view).
  • Left atrial (or left atrial appendage) thrombus (confirmed by TEE or MSCT).
  • Severe structural heart disease (e.g., hypertrophic obstructive cardiomyopathy, severe valvular heart disease) or uncontrolled heart failure (NYHA class III or IV).
Show all 12Show fewer
  • Thyroid dysfunction (e.g., uncontrolled hyperthyroidism).
  • Severe hepatic or renal impairment (AST or ALT >= 3 times upper limit of normal; SCr > 3.5 mg/dl or Ccr < 30 ml/min).
  • History of stroke within the past 6 months.
  • History of surgery within the past 3 months.
  • Pregnant women.
  • Life expectancy < 12 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heng Cai, Master contact

+86 13821378394

yuong1101@163.com

Xue Li contact

+86 13752697996

xuelizyy@tmu.edu.cn

China1 site

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

Official title: Clinical Application Evaluation of a Novel Pulsed Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation and Its Protective Effect on Left Atrial Function

This is a prospective clinical study aiming to evaluate the clinical efficacy and safety of a novel domestic pulsed field ablation (PFA) system in the treatment of paroxysmal atrial fibrillation (PAF), and to specifically assess its protective effect on left atrial function.

Approximately 200-220 patients with paroxysmal atrial fibrillation are planned to be enrolled. Participants will be treated with the novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system.

Read more

The primary objectives include:

Efficacy: Immediate pulmonary vein isolation success rate, and freedom from atrial arrhythmias (>30 seconds) at 12 months post-procedure.

Safety: Incidence of major complications (such as cardiac tamponade, stroke, pulmonary vein stenosis, phrenic nerve palsy).

Left Atrial Function: Dynamic changes in echocardiographic parameters (e.g., LAVI, LVEF, E/A, LASr/cd/ct) and serum biomarkers (e.g., troponin, BNP, inflammatory markers) at multiple time points before and after the procedure.

Patients will be followed up for 12 months to evaluate the long-term outcomes and quality of life improvement (EQ-5D-5L). The study duration is expected to be 36 months (October 2025 to September 2028).

Being tested
Novel Pulsed Field Ablation System, Radiofrequency 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.

  • Novel Pulsed Field Ablation SystemDevice

    Use a novel PFA system (YTL-PFA01) and a three-dimensional electroanatomical mapping system to perform pulmonary vein isolation.

  • Radiofrequency Ablation CatheterDevice

    Use conventional radiofrequency ablation catheters to perform pulmonary vein isolation.

Study groups in NCT07865221
Study groupRoleWhat they receive
PFA GroupExperimentalPatients will be treated with the novel Pulsed Field Ablation system
Receives: Device: Novel Pulsed Field Ablation System
RFCA GroupActive comparatorPatients will be treated with conventional radiofrequency catheter ablation.
Receives: Device: Radiofrequency Ablation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from atrial arrhythmia recurrence at 12 months

    Percentage of participants free from documented atrial arrhythmias (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting >30 seconds at 12 months post-ablation.

    Measured: 12 months post-procedure

  2. Incidence of major procedure-related complications

    Incidence of major adverse events related to the procedure, such as cardiac tamponade, thromboembolic events, vascular complications, pulmonary vein stenosis, and phrenic nerve injury.

    Measured: Within 12 months post-procedure

Secondary outcomes (13)

  1. Change in left atrial volume index (LAVI)

    Change from baseline in left atrial volume index (LAVI) at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  2. Change in left ventricular ejection fraction (LVEF)

    Change from baseline in left ventricular ejection fraction (LVEF) at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  3. Change in mitral inflow E/A ratio

    Change from baseline in E/A ratio at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  4. Change in left atrial reservoir strain (LASr)

    Change from baseline in LASr at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  5. Change in tissue Doppler a'/e' ratio

    Change from baseline in a'/e' ratio at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  6. Change in left atrial conduit strain (LAScd)

    Change from baseline in LAScd at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  7. Change in left atrial contractile strain (LASct)

    Change from baseline in LASct at each follow-up visit.

    Measured: Baseline to 12 months post-procedure

  8. Change in quality of life score

    Change from baseline in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) health-related quality of life questionnaire score. The scale consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The minimum score for each dimension is 1 (no problems) and the maximum score is 5 (unable to/extreme problems), with a total score range of 5 to 25. Higher scores indicate a worse health-related quality of life outcome.

    Measured: Baseline to 12 months post-procedure

  9. Change in myocardial injury markers (troponin)

    Change from baseline in troponin at different time points.

    Measured: Baseline to 12 months post-procedure

  10. Change in inflammatory markers (CRP)

    Change from baseline in C-reactive protein (CRP) at different time points.

    Measured: From the initial assessment to 12 months after the procedure

  11. Change in inflammatory markers (IL-6)

    Change from baseline in interleukin-6 (IL-6) at different time points.

    Measured: Baseline to 12 months post-procedure

  12. Change in fibrosis markers (Galectin-3)

    Change from baseline in Galectin-3 at different time points.

    Measured: Baseline to 12 months post-procedure

  13. Change in fibrosis markers (sST2)

    Change from baseline in soluble ST2 (sST2) at different time points.

    Measured: Baseline to 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07865221
Sponsor's protocol ID
25ZXSWSY00530
Other IDs
25ZXSWSY00530
Status last verified
Sep 2026
First submitted
28 Sep 2026
Last updated
14 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Novel Pulsed Field Ablation System and Radiofrequency Ablation Catheter in people with Paroxysmal Atrial Fibrillation and Pulsed Field Ablation, run by Tianjin Medical University General Hospital 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 12 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 14 Oct 2026. 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?

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 Heng Cai, Master (+86 13821378394, yuong1101@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from atrial arrhythmia recurrence at 12 months (time frame: 12 months post-procedure). 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 NCT07865221.

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 14 Oct 2026.

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