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

Early Phase 1RecruitingNCT07662655

Xiamen Cardiovascular Hospital, Xiamen University60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pulmonary Hypertension Pulmonary Hypertension Associated With HFpEF

Interventions

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PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A,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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. \|

Outcomes

Primary Outcomes

Clinical worsening event

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