200
Participants
Start Date
March 19, 2025
Primary Completion Date
December 30, 2028
Study Completion Date
December 30, 2028
Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China
PADN: Contrast pulmonary artery (PA) angiography will be performed to localize the pulmonary artery bifurcation level and calculate the PA diameter. Once the anatomy deemed acceptable, the radiofrequency ablation catheter will be introduced into ostium of the left PA and the distal bifurcation area of the main PA. The catheter will be manoeuvred within the PA to allow energy delivery in a circumferential manner to ensure that the electrodes are tightly in contact with the endovascular surface. About three ablations at 45-55 # for 120 seconds each will be performed in ostium of the left PA and the distal bifurcation area of the main PA. For non-atrial fibrillation patients, dual antiplatelet therapy for 1 month after PADN is recommended. Patients with atrial fibrillation should continue new oral anticoagulants and patients who underwent metal valve replacement should continued oral warfarin anticoagulation according to guidelines, which could determined by the physician.
RECRUITING
The First Affiliated Hospital with Nanjing Medical University, Nanjing
Pulnovo Medical (Wuxi) Co., Ltd.
INDUSTRY