Clinical Research Directory

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

Sponsor: Ruijin Hospital

Summary

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.

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