NCT07819175Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 8 Sept 2026
- Start date
- 8 Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Ruijin Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07819175
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 8 Oct 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
Lab values
- Significant cardiac dysfunction or structural abnormality: LVEF \< 50% or left atrial anteroposterior diameter \> 46 mm;
- Severe renal insufficiency (eGFR \< 30);
Other
- Atrial fibrillation due to reversible causes (e.g., hyperthyroidism);
- Pregnant or lactating women;
- Life expectancy \< 1 year;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hostpial Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.