Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study
Pulmonary HypertensionPulmonary Hypertension Associated With HFpEF
Investigational drug(s) / intervention(s)
Percutaneous Pulmonary Artery Denervation (PADN)Control group (receiving standard medical therapy alone)
Percutaneous Pulmonary Artery Denervation (PADN): \*\*PADN Procedure Steps:\*\*
1. Non-Selective Pulmonary Artery Angiography
2. PADN Ablation Target Selection
3. Hemodynamic Assessment
4. Establishment of the PADN® RF Catheter Delivery Rail
5. PADN® RF Catheter Delivery
6. Performance of the PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A, B, and C. . Temperature-controlled mode is recommended for radiofrequency ablation, with the ablation temperature set to 50°C and the total ablation time set to 150 seconds. The pulmonary artery radiofrequency ablation generator will automatically start calculating the effective ablation time (ET) once the ablation temperature reaches 45°C. Ablation at each target point is considered effective when the ET reaches at least 120 seconds.
7. Completion of the PADN
Control group (receiving standard medical therapy alone): Control group (receiving standard medical therapy alone)
Study summary
this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years and ≤80 years;
2. Diagnosed with pulmonary hypertension (defined as mPAP \>20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;
3. No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);
4. Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;
5. Willing to comply with the treatment and follow-up schedule required by the protocol
Exclusion Criteria:
1. Cardiac index (CI) \< 1.5 L/min/m²;
2. Severe renal insufficiency (creatinine clearance rate (CrCL) \< 30 mL/min);
3. Left ventricular ejection fraction (EF) \<30% on echocardiography;
4. Severe hematological disease or severe bleeding tendency (platelet count \<10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);
5. Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;
6. Acute systemic infectious disease;
7. Poor general condition due to various systemic diseases;
8. Pulmonary veno-occlusive disease;
9. Cachexia;
10. Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;
11. Anticipated to undergo other surgical or interventional procedures within 6 months;
12. Life expectancy \<12 months;
13. Allergy to the drugs or metal materials used in the study;
14. Women who are breastfeeding, pregnant, or planning to become pregnant within one year;
15. Participation in another drug or medical device clinical trial within 3 months prior to screening;
16. Any condition deemed unsuitable for participation in this clinical trial by the investigator. \|
Primary outcome measure(s)
Clinical worsening event — From enrollment up to 12 months defined as the occurrence of any of the following:
1. Worsening heart failure symptoms requiring intravenous therapy (inotropes, diuretics, or vasodilators);
2. Heart failure-related rehospitalization;
3. Decrease in 6MWD from baseline by \>10% or \>30 meters;
4. Need for heart/lung transplantation;
5. All-cause death
Trial sites (1)
Facility
City
Region
Status
Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
Xiamen
Fujian
Recruiting
More Xiamen Cardiovascular Hospital, Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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