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Recruiting NCT07039604

Real-World Study of PADN for the Treatment of PAH

— Observational Pulmonary Hypertension Hypertension, Pulmonary Arterial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension, Hypertension, Pulmonary Arterial. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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. A

Primary outcome measures

  • Clinical worsening [Time frame: 1 year]
Secondary outcome measures (11)
  • 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 [Time frame: 6 months, 1, 2, 3, and 5 years]
  • Echocardiographic changes from baseline [Time frame: 6 months, 1, 2, 3, and 5 years]
  • Echocardiographic changes from baseline [Time frame: 6 months, 1, 2, 3, and 5 years]
  • Echocardiographic changes from baseline [Time frame: 6 months, 1, 2, 3, and 5 years]
  • Echocardiographic changes from baseline [Time frame: 6 months, 1, 2, 3, and 5 years]
  • Echocardiographic changes from baseline [Time frame: 6 months, 1, 2, 3, and 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Affiliated Hospital with Nanjing Medical University — Nanjing

Identifiers

NCT: NCT07039604 · PADN-PMS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗