Real-World Study of PADN for the Treatment of PAH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPulnovo Medical (Wuxi) Co., Ltd.
About this trial
Real-World Study of PADN for the Treatment of PAH
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Enhancor™ Radiofrequency Catheter, Pulnovo Medical (Wuxi) CO., Ltd., Wuxi, Jiangsu, China
DevicePADN: 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
WHO Functional Class changes from baseline
Time frame
6 months, 1, 2, 3, and 5 years2
NT-proBNP/BNP levels from baseline
Time frame
6 months, 1, 2, 3, and 5 years3
6MWD changes from baseline
Time frame
6 months, 1, 2, 3, and 5 years4
Incidence of pulmonary infections
Time frame
Through study completion, an average of 5 yearsSponsors and contacts
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Source ClinicalTrials.gov