Real-World Study of PADN for the Treatment of PAH

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

March 19, 2025

Primary Completion Date

December 30, 2028

Study Completion Date

December 30, 2028

Conditions
Pulmonary HypertensionHypertension, Pulmonary Arterial
Interventions
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.

Trial Locations (1)

Unknown

RECRUITING

The First Affiliated Hospital with Nanjing Medical University, Nanjing

All Listed Sponsors
lead

Pulnovo Medical (Wuxi) Co., Ltd.

INDUSTRY