Pulsed field ablation with or without superior vena cava isolation for persistent atrial fibrillation
Compares two heart ablation procedures in people with persistent atrial fibrillation having a first ablation.
Plain-language title generated from the registry record
Registry title: Pulsed Field Ablation for the Treatment of Persistent Atrial Fibrillation: Pulmonary Vein Plus Superior Vena Cava Isolation Versus Pulmonary Vein Isolation Alone-A Prospective, Multicenter, Randomized Controlled Study
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07819175, who can take part
Where in China
- Ruijin Hostpial Shanghai Jiaotong University School of MedicineShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT07819175
- Record updated
- 14 September 2026
- Original description
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure.Read full original descriptionShow less
Pulsed Field Ablation for the Treatment of Persistent Atrial Fibrillation: Pulmonary Vein Plus Superior Vena Cava Isolation Versus Pulmonary Vein Isolation Alone-A Prospective, Multicenter, Randomized Controlled Study
his study is for people aged 18 to 75 who have persistent atrial fibrillation (AFib) that has lasted less than one year and who are having their first catheter ablation procedure.
Atrial fibrillation is a common heart rhythm problem. A standard treatment is a catheter procedure called pulmonary vein isolation (PVI), which uses energy to disconnect the pulmonary veins from the rest of the heart. However, in persistent AFib, the heart rhythm often returns after PVI alone.
Some people also have abnormal electrical signals coming from a large vein above the right atrium called the superior vena cava (SVC). This study tests whether adding SVC isolation (SVCI) to the standard PVI procedure works better than PVI alone.
The study will use pulsed field ablation (PFA), a newer non-heating technology that targets heart muscle cells and may cause less damage to nearby structures such as the food pipe and nerves.
About 340 participants will be enrolled from around 10 hospitals in China. Using a computer process, half will be assigned to PVI alone and half to PVI plus SVC isolation. Neither the doctor nor the participant will be blinded to the group assignment because the difference between the two procedures is visible.
All participants will be followed for 12 months after the procedure. The main question is: after a 3-month healing period, how many people stay free from AFib and other atrial rhythm problems for the remaining 9 months without needing more ablation or new rhythm medicines? The study also looks at safety, quality of life, hospital stays, and whether the heart rhythm returns.
Inclusion: Persistent atrial fibrillation (AFib) duration < 1 year; Age 18-75 years; Willing to participate in this study, capable of understanding, and has signed the informed consent form; able to complete postoperative follow-up according to the protocol.
Exclusion: Previous left atrial ablation or cardiac surgery (including left atrial appendage closure); Previous pulmonary vein stent, pulmonary vein stenosis, or superior vena cava stenosis; Previous unilateral phrenic nerve palsy; Any cardiac surgery, myocardial infarction, PCI/PTCA, or coronary stent implantation within 3 months prior to signing informed consent; Stroke or TIA within 6 months prior to signing informed consent; Currently participating in or expected to participate in another drug/device/biologic clinical trial during the study period; Intracardiac thrombus, drug or alcohol addiction, unwillingness or inability to complete follow-up; Previous catheter ablation for atrial fibrillation; Presence of permanent pacemaker, CRT, implantable cardiac monitor, or any type of ICD; Any prosthetic heart valve or moderate-to-severe (grade 3-4) valvular regurgitation/stenosis; Unstable angina, NYHA class III/IV heart failure, primary pulmonary hypertension, rheumatic heart disease, or hypertrophic cardiomyopathy; Thrombocytosis/thrombocytopenia, any disease contraindicating long-term anticoagulation, active systemic infection; Primary severe sick sinus syndrome; Significant cardiac dysfunction or structural abnormality: LVEF < 50% or left atrial anteroposterior diameter > 46 mm; Severe renal insufficiency (eGFR < 30); Atrial fibrillation due to reversible causes (e.g., hyperthyroidism); Pregnant or lactating women; Life expectancy < 1 year.