Real-World Study of PADN for the Treatment of PAH

N/ARecruitingNCT07039604

Pulnovo Medical (Wuxi) Co., Ltd.200 enrolled

Overview

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Pulmonary Hypertension Hypertension, Pulmonary Arterial

Interventions

Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, ChinaDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Clinical worsening

Clinical worsening events defined as any of the following during the study period: 1. PAH-related rehospitalization. 2. Addition of PAH-targeted therapies (increased types/dose of PAH-targeted drugs or diuretics). 3. ≥10% or ≥30-meter reduction in 6-Minute Walk Distance (6MWD) from baseline. 4. Atrial septostomy. 5. Need for lung transplantation. 6. Cardiovascular death.

Time frame: 1 year

Secondary Outcomes

WHO Functional Class changes from baseline

Time frame: 6 months, 1, 2, 3, and 5 years

NT-proBNP/BNP levels from baseline

Time frame: 6 months, 1, 2, 3, and 5 years

6MWD changes from baseline

Time frame: 6 months, 1, 2, 3, and 5 years

Incidence of pulmonary infections

Time frame: Through study completion, an average of 5 years

All-cause death

Time frame: Through study completion, an average of 5 years

Echocardiographic changes from baseline

Right atrial diameter (RAD)

Time frame: 6 months, 1, 2, 3, and 5 years

Echocardiographic changes from baseline

Right ventricular end-diastolic diameter (RVDd)

Time frame: 6 months, 1, 2, 3, and 5 years

Echocardiographic changes from baseline

Tricuspid annular plane systolic excursion (TAPSE)

Data from ClinicalTrials.gov

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