PADN treatment for pulmonary arterial hypertension
Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)
This project will try pulmonary artery denervation (PADN) with the Enhancor radiofrequency catheter in people with pulmonary arterial hypertension who underwent the procedure since March 2024 to collect real-world outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Pulnovo Medical (Wuxi) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07039604 on ClinicalTrials.gov |
What this trial studies
This observational real-world registry will collect clinical, hemodynamic, and safety data on patients with pulmonary arterial hypertension who underwent pulmonary artery denervation (PADN) with the Enhancor™ radiofrequency catheter starting in March 2024. Investigators will enroll consenting patients at The First Affiliated Hospital with Nanjing Medical University and abstract baseline demographics, procedural details, medications, hemodynamics, functional status, and follow-up events from medical records. No interventional treatments are assigned by the protocol; follow-up will occur per routine care and scheduled data collection visits. The aim is to characterize outcomes and device performance in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with pulmonary arterial hypertension who received PADN with the Enhancor catheter since March 2024, have no contraindications to the procedure, and can provide informed consent and follow-up data.
Not a fit: Patients without pulmonary arterial hypertension, those who did not receive PADN, or individuals with severe comorbidities that limit recovery may not gain benefit from the procedure or this registry's findings.
Why it matters
Potential benefit: If successful, the registry could show that PADN lowers pulmonary pressure and improves symptoms and exercise capacity in some patients, supporting wider use or further trials.
How similar studies have performed: Small trials and registries of pulmonary artery denervation have reported improved hemodynamics and symptoms in some patients, but evidence remains limited and additional real-world data are needed.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.