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.
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.
Significant cardiac dysfunction or structural abnormality: LVEF < 50% or left atrial anteroposterior diameter > 46 mm;
Previous left atrial ablation or cardiac surgery (including left atrial appendage closure);
Presence of permanent pacemaker, CRT, implantable cardiac monitor, or any type of ICD;
Previous pulmonary vein stent, pulmonary vein stenosis, or superior vena cava stenosis;
Parallel
Pulsed Field Ablation - pulmonary vein isolation
DevicePulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI). Ablation is performed sequentially at each pulmonary vein and the pulmonary vein antrum, with the procedural endpoint of durable bidirectional electrical isolation.
Pulsed Field Ablation - Pulmonary Vein Isolation + Superior Vena Cava Isolation
DevicePulsed Field Ablation (PFA) using a commercially available pulsed field ablation catheter to perform pulmonary vein isolation (PVI) followed by electrophysiological assessment for superior vena cava (SVC) triggers and additional superior vena cava isolation (SVCI) at the SVC-right atrium junction.
Treatment success from 3 months after the ablation (after the blanking period) through the 12-month follow-up
Incidence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) during the 3-month blanking period after the index ablation
Time to first recurrence of atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL)
Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
Change in quality of life from baseline, as assessed by the Atrial Fibrillation Effect on 12-Item Short Form Health Survey (SF-12) scores
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This trial is not recruiting at the moment. You can still explore other options:
