NCT07039604

Real-World Study of PADN for the Treatment of PAH

Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Pulnovo Medical (Wuxi) Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

Real-World Study of PADN for the Treatment of PAH

Conditions

• Pulmonary Hypertension
• Hypertension, Pulmonary Arterial

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-03-19
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: China