Persistent Atrial Fibrillation
Conditions
Brief summary
This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.
Detailed description
No other detailed description.
Interventions
PROCEDUREAbnormal left atrial substrate
Left atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.
PROCEDUREsuperior vena cava isolation
Left atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Sponsors
Hangzhou Dinova EP Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Older than 18 years. 2. Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days. 3. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion criteria
1. Atrial fibrillation is secondary to thyroid disease or other reversible factors. 2. Evidence of left atrial or left atrial appendage thrombus on imaging examination. 3. Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation. 4. Left ventricular ejection fraction \<40% or New York Heart Association (NYHA) class III/IV. 5. Left atrial anteroposterior diameter \>55 mm. 6. Unstable angina. 7. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment. 8. Previous catheter ablation or surgical ablation for atrial fibrillation. 9. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery. 10. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings. 11. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation. 12. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding. 13. Active systemic infection. 14. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or history of renal dialysis. 15. Severe hepatic dysfunction. 16. Pregnancy or breastfeeding. 17. Life expectancy \<12 months (e.g., advanced malignancy). 18. Current or anticipated participation in other drug or device clinical trials. 19. Any other condition or abnormality deemed by the investigator to warrant exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-month atrial fibrillation (AF) ablation success rate | 12 months post-procedure | Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute pulmonary vein ablation success rate and superior vena cava isolation rate. | Immediately post-procedure | Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage \< 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block). |
| Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only) | Immediately post-procedure | Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage \< 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing. |
| Procedure-related time | Immediately post-procedure | Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time. |
| Early recurrence rate of atrial arrhythmia (within the blanking period) | Within 3 months post-procedure | Early recurrence rate of atrial arrhythmia (within the blanking period) |
| Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period. | Within 12 months post-procedure | Incidence of symptomatic and asymptomatic atrial fibrillation events after the end of the blanking period |
| Incidence of repeat ablation after the blanking period | Within 12 months post-procedure | Incidence of repeat ablation after the blanking period |
| Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation. | Within 12 months post-fist procedure. | Rate of maintenance of pulmonary vein 、left atrial posterior wall and superior vena cava isolation in patients undergoing repeat ablation. |
| Improvement in Atrial fibrillation burden. | 3、6 and 12 months post-procedure. | Evaluate the improvement in postoperative atrial fibrillation burden via ambulatory electrocardiography. |
| Cardiac function assessment by NYHA | within 12 months post-procedure | Cardiac function was assessed relative to baseline using the NYHA classification. |
| The postoperative quality of life was assessed using the Atrial Fibrillation-Specific Quality of Life Scale. | Within 12 months post-procedure | Assess the improvement in health-related quality of life after atrial fibrillation surgery using the Atrial Fibrillation Effect on QualiTy of Life score. |
Countries
China
Contacts
CONTACTGUODONG NIU
Outcome results
None listed