Recruiting
Real-World Study of PADN for the Treatment of PAH
Real-World Study of PADN for the Treatment of PAH
ClinicalTrials.gov IDNCT07039604
PhaseNot Applicable
Enrollment200
SponsorPulnovo Medical (Wuxi) Co., Ltd.
AgeNo minimum reported
SexALL
Conditions studied
Pulmonary Hypertension, Hypertension, Pulmonary Arterial
About this study
Real-World Study of PADN for the Treatment of PAH
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.
Primary outcomes
- Clinical worsening (1 year)
Eligibility information
Inclusion Criteria:
1. Diagnosed with PAH and received PADN procedure since March 2024.
2. No contraindications to procedure.
3. Able to provide informed consent and authorize use of health/research data.
4. Compliant with treatment and follow-up requirements.
Exclusion Criteria:
None specified.
Study locations
- The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.