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Real-World Study of PADN for the Treatment of PAH
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhancorâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical worsening | Clinical worsening events defined as any of the following during the study period:
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| WHO Functional Class changes from baseline | 6 months, 1, 2, 3, and 5 years | |
| NT-proBNP/BNP levels from baseline | 6 months, 1, 2, 3, and 5 years | |
| 6MWD changes from baseline |
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Inclusion Criteria:
Exclusion Criteria:
None specified.
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Patients diagnosed with pulmonary arterial hypertension (PAH) who have undergone PADN procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| 6 months, 1, 2, 3, and 5 years |
| Incidence of pulmonary infections | Through study completion, an average of 5 years |
| All-cause death | Through study completion, an average of 5 years |
| Echocardiographic changes from baseline | Right atrial diameter (RAD) | 6 months, 1, 2, 3, and 5 years |
| Echocardiographic changes from baseline | Right ventricular end-diastolic diameter (RVDd) | 6 months, 1, 2, 3, and 5 years |
| Echocardiographic changes from baseline | Tricuspid annular plane systolic excursion (TAPSE) | 6 months, 1, 2, 3, and 5 years |
| Echocardiographic changes from baseline | Left ventricular ejection fraction (LVEF) | 6 months, 1, 2, 3, and 5 years |
| Echocardiographic changes from baseline | Left atrial diameter (LAD) | 6 months, 1, 2, 3, and 5 years |
| Echocardiographic changes from baseline | Left ventricular end-diastolic diameter (LVDd) | 6 months, 1, 2, 3, and 5 years |
| D002318 |
| Cardiovascular Diseases |