Paroxysmal Atrial Fibrillation, Pulsed Field Ablation, Catheter Ablation, Left Atrial Function, Cardiology
Conditions
Brief 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).
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.
Use conventional radiofrequency ablation catheters to perform pulmonary vein isolation.
Sponsors
Tianjin Medical University General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from atrial arrhythmia recurrence at 12 months | 12 months post-procedure | Percentage of participants free from documented atrial arrhythmias (atrial fibrillation, atrial flutter, or atrial tachycardia) lasting \>30 seconds at 12 months post-ablation. |
| Incidence of major procedure-related complications | Within 12 months post-procedure | Incidence of major adverse events related to the procedure, such as cardiac tamponade, thromboembolic events, vascular complications, pulmonary vein stenosis, and phrenic nerve injury. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in left atrial volume index (LAVI) | Baseline to 12 months post-procedure | Change from baseline in left atrial volume index (LAVI) at each follow-up visit. |
| Change in left ventricular ejection fraction (LVEF) | Baseline to 12 months post-procedure | Change from baseline in left ventricular ejection fraction (LVEF) at each follow-up visit. |
| Change in mitral inflow E/A ratio | Baseline to 12 months post-procedure | Change from baseline in E/A ratio at each follow-up visit. |
| Change in left atrial reservoir strain (LASr) | Baseline to 12 months post-procedure | Change from baseline in LASr at each follow-up visit. |
| Change in tissue Doppler a'/e' ratio | Baseline to 12 months post-procedure | Change from baseline in a'/e' ratio at each follow-up visit. |
| Change in left atrial conduit strain (LAScd) | Baseline to 12 months post-procedure | Change from baseline in LAScd at each follow-up visit. |
| Change in left atrial contractile strain (LASct) | Baseline to 12 months post-procedure | Change from baseline in LASct at each follow-up visit. |
| Change in quality of life score | Baseline to 12 months post-procedure | 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. |
| Change in myocardial injury markers (troponin) | Baseline to 12 months post-procedure | Change from baseline in troponin at different time points. |
| Change in inflammatory markers (CRP) | From the initial assessment to 12 months after the procedure | Change from baseline in C-reactive protein (CRP) at different time points. |
| Change in inflammatory markers (IL-6) | Baseline to 12 months post-procedure | Change from baseline in interleukin-6 (IL-6) at different time points. |
| Change in fibrosis markers (Galectin-3) | Baseline to 12 months post-procedure | Change from baseline in Galectin-3 at different time points. |
| Change in fibrosis markers (sST2) | Baseline to 12 months post-procedure | Change from baseline in soluble ST2 (sST2) at different time points. |
Countries
China
Contacts
CONTACTHeng Cai, Master
CONTACTXue Li
Outcome results
None listed