Real-World Study of PADN for the Treatment of PAH

NCT07039604 | Recruiting

• 1 other identifier: PADN-PMS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Real-World Study of PADN for the Treatment of PAH

Conditions

Pulmonary Hypertension; Hypertension, Pulmonary Arterial

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (11)

• WHO Functional Class changes from baseline

  6 months, 1, 2, 3, and 5 years

• NT-proBNP/BNP levels from baseline

  6 months, 1, 2, 3, and 5 years

• 6MWD changes from baseline

  6 months, 1, 2, 3, and 5 years

• Incidence of pulmonary infections

  Through study completion, an average of 5 years

• All-cause death

  Through study completion, an average of 5 years

Interventions

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

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 Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.

You may qualify if:

• 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.

You may not qualify if:

• None specified.

Sponsors & Collaborators

• Pulnovo Medical (Wuxi) Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 26, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

CN (1)