RecruitingNCT07039604

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)


Sponsor

Pulnovo Medical (Wuxi) Co., Ltd.

Enrollment

200 participants

Start Date

Mar 19, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Real-World Study of PADN for the Treatment of PAH


Eligibility

Inclusion Criteria4

  • Diagnosed with PAH and received PADN procedure since March 2024.
  • No contraindications to procedure.
  • Able to provide informed consent and authorize use of health/research data.
  • Compliant with treatment and follow-up requirements.

Exclusion Criteria1

  • None specified.

Interventions

DEVICEEnhancor™ 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.


Locations(1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

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NCT07039604


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