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NCT Number: NCT07039604

Real-World Study of PADN for the Treatment of PAH

Real-World Study of PADN for the Treatment of PAH

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Hypertension, Pulmonary Arterial Lung Diseases Pulmonary Arterial Hypertension Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Shao-liang Chen, MD

CONTACT

[email protected]

+86 13605157029

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

None specified.

Treatment and study plan

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.

Primary outcomes

  1. Clinical worsening

    Time frame: 1 year

    Clinical worsening events defined as any of the following during the study period:

    • PAH-related rehospitalization.
    • Addition of PAH-targeted therapies (increased types/dose of PAH-targeted drugs or diuretics).
    • ≥10% or ≥30-meter reduction in 6-Minute Walk Distance (6MWD) from baseline.
    • Atrial septostomy.
    • Need for lung transplantation.
    • Cardiovascular death.

Secondary outcomes

  1. WHO Functional Class changes from baseline

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

  2. NT-proBNP/BNP levels from baseline

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

  3. 6MWD changes from baseline

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

  4. Incidence of pulmonary infections

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

  5. All-cause death

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

  6. Echocardiographic changes from baseline

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

    Right atrial diameter (RAD)

  7. Echocardiographic changes from baseline

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

    Right ventricular end-diastolic diameter (RVDd)

  8. Echocardiographic changes from baseline

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

    Tricuspid annular plane systolic excursion (TAPSE)

  9. Echocardiographic changes from baseline

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

    Left ventricular ejection fraction (LVEF)

  10. Echocardiographic changes from baseline

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

    Left atrial diameter (LAD)

  11. Echocardiographic changes from baseline

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

    Left ventricular end-diastolic diameter (LVDd)

Sponsors and collaborators

Lead sponsor

Pulnovo Medical (Wuxi) Co., Ltd.

Industry

Registry information

Official study title

Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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