CClinicalTrials.gg
Sign In
Not yet recruitingNCT07865221Updated Oct 8, 2026

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

An interventional study of Novel Pulsed Field Ablation System and Radiofrequency Ablation Catheter in Paroxysmal Atrial Fibrillation, Pulsed Field Ablation and Catheter Ablation, sponsored by Tianjin Medical University General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Tianjin Medical University General Hospital · Not applicable, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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).

02

Conditions studied

  • Paroxysmal Atrial Fibrillation
  • Pulsed Field Ablation
  • Catheter Ablation
  • Left Atrial Function
  • Cardiology

Browse trials for

03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 220 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Tianjin Medical University General Hospital is the lead sponsor of 72 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Previous radiofrequency catheter ablation (RFCA) for atrial fibrillation.
  2. Presence of a cardiac pacemaker or post-left atrial appendage closure.
  3. Thrombocytopenia (PLT \< 80×10\^9/L) or contraindications to anticoagulation (e.g., warfarin, heparin, direct factor Xa inhibitors, direct thrombin inhibitors).
  4. Left atrial anterior-posterior diameter > 55 mm (by transthoracic echocardiography, parasternal long-axis view).
  5. Left atrial (or left atrial appendage) thrombus (confirmed by TEE or MSCT).
  6. Severe structural heart disease (e.g., hypertrophic obstructive cardiomyopathy, severe valvular heart disease) or uncontrolled heart failure (NYHA class III or IV).
  7. Thyroid dysfunction (e.g., uncontrolled hyperthyroidism).
  8. Severe hepatic or renal impairment (AST or ALT >= 3 times upper limit of normal; SCr > 3.5 mg/dl or Ccr \< 30 ml/min).
  9. History of stroke within the past 6 months.
  10. History of surgery within the past 3 months.
  11. Pregnant women.
  12. Life expectancy \< 12 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    PFA Group

    Patients will be treated with the novel Pulsed Field Ablation system

    Device: Novel Pulsed Field Ablation System

  • Active comparator
    RFCA Group

    Patients will be treated with conventional radiofrequency catheter ablation.

    Device: Radiofrequency Ablation Catheter

Interventions

  • DeviceNovel Pulsed Field Ablation System

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

  • DeviceRadiofrequency Ablation Catheter

    Use conventional radiofrequency ablation catheters to perform pulmonary vein isolation.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Within 12 months post-procedure

Secondary outcomes

  1. Change in left atrial volume index (LAVI)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline to 12 months post-procedure

  4. Change in left atrial reservoir strain (LASr)

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

    Time frame: 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.

    Time frame: Baseline to 12 months post-procedure

  6. Change in left atrial conduit strain (LAScd)

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

    Time frame: Baseline to 12 months post-procedure

  7. Change in left atrial contractile strain (LASct)

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

    Time frame: Baseline to 12 months post-procedure

  8. Change in quality of life score

    Change from baseline in the EQ-5D-5L health-related quality of life questionnaire score.

    Time frame: Baseline to 12 months post-procedure

  9. Change in myocardial injury markers (troponin)

    Change from baseline in troponin at different time points.

    Time frame: Baseline to 12 months post-procedure

  10. Change in inflammatory markers (CRP)

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

    Time frame: 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.

    Time frame: Baseline to 12 months post-procedure

  12. Change in fibrosis markers (Galectin-3)

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

    Time frame: Baseline to 12 months post-procedure

  13. Change in fibrosis markers (sST2)

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

    Time frame: Baseline to 12 months post-procedure

07

Study locations

1 site
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality 300052, China
08

References and documents

Study documents

  • Study protocol · Oct 3, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865221
Lead sponsor
Tianjin Medical University General Hospital
Responsible party
Heng Cai (Chief Physician, Tianjin Medical University General Hospital) — Principal investigator
First posted
Oct 8, 2026
Start date
Oct 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Oct 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Heng Cai, Master
Contact
yuong1101@163.com
+86 13821378394
Xue Li
Contact
xuelizyy@tmu.edu.cn
+86 13752697996

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Atrial Fibrillation→

Other studies from this sponsor

Tianjin Medical University General Hospital

Start the discussion