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NCT07590661

A Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

Sponsor: Hangzhou Dinova EP Technology Co., Ltd

View on ClinicalTrials.gov

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.

Official title: Prospective, Multicenter, Randomized Controlled Study on the Therapeutic Value of Additional Left Atrial Posterior Wall Isolation Guided by Voltage Mapping in Persistent Atrial Fibrillation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2026-04-30

Completion Date

2029-02

Last Updated

2026-05-15

Healthy Volunteers

Yes

Conditions

Persistent Atrial Fibrillation

Interventions

PROCEDURE

superior 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.

PROCEDURE

Abnormal 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.

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.

Locations (1)

Fuwai Yunnan Hospital

Kunming, Yunnan, China