Pulmonary HypertensionNCT07039604
Real-World Study of PADN for the Treatment of PAH
An observational study of Pulmonary Hypertension and Hypertension, Pulmonary Arterial, run by Pulnovo Medical (Wuxi) Co., Ltd. at 1 site in China.
Trial summary
Real-World Study of PADN for the Treatment of PAH Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension, Hypertension, Pulmonary Arterial
- What is being tested?
- Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.
Who may be able to join
- 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.
Who cannot join
- None specified.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Shao-liang Chen, MD, +86 13605157029, chmengx@126.com
About this study
Official title: Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)
Real-World Study of PADN for the Treatment of PAH
- Being tested
- Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical worsening
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.
Measured: 1 year
Secondary outcomes (11)
WHO Functional Class changes from baseline
Measured: 6 months, 1, 2, 3, and 5 years
NT-proBNP/BNP levels from baseline
Measured: 6 months, 1, 2, 3, and 5 years
6MWD changes from baseline
Measured: 6 months, 1, 2, 3, and 5 years
Incidence of pulmonary infections
Measured: Through study completion, an average of 5 years
All-cause death
Measured: Through study completion, an average of 5 years
Echocardiographic changes from baseline
Right atrial diameter (RAD)
Measured: 6 months, 1, 2, 3, and 5 years
Echocardiographic changes from baseline
Right ventricular end-diastolic diameter (RVDd)
Measured: 6 months, 1, 2, 3, and 5 years
Echocardiographic changes from baseline
Tricuspid annular plane systolic excursion (TAPSE)
Measured: 6 months, 1, 2, 3, and 5 years
Echocardiographic changes from baseline
Left ventricular ejection fraction (LVEF)
Measured: 6 months, 1, 2, 3, and 5 years
Echocardiographic changes from baseline
Left atrial diameter (LAD)
Measured: 6 months, 1, 2, 3, and 5 years
Echocardiographic changes from baseline
Left ventricular end-diastolic diameter (LVDd)
Measured: 6 months, 1, 2, 3, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start19 Mar 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulnovo Medical (Wuxi) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039604
- Sponsor's protocol ID
- PADN-PMS
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Arterial Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT07039604
- Acronym / sponsor ID
- PADN-PMS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pulnovo Medical (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Real-World Study of PADN for the Treatment of PAH
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None specified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, ChinaPADN: 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. | Device | – |
Primary outcome
Clinical worsening
Time frame: 1 year
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.
11 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Hypertension, Pulmonary Arterial, run by Pulnovo Medical (Wuxi) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical worsening (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.