RecruitingEarly Phase 1NCT07662655

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

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Enrollment

60 participants

Start Date

Jun 6, 2026

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Pulmonary Hypertension Associated With HFpEF

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

Age ≥18 years and ≤80 years;
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;
No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);
Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;
Willing to comply with the treatment and follow-up schedule required by the protocol

Exclusion Criteria16

Cardiac index (CI) < 1.5 L/min/m²;
Severe renal insufficiency (creatinine clearance rate (CrCL) < 30 mL/min);
Left ventricular ejection fraction (EF) <30% on echocardiography;
Severe hematological disease or severe bleeding tendency (platelet count <10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);
Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or interventional treatment;
Acute systemic infectious disease;
Poor general condition due to various systemic diseases;
Pulmonary veno-occlusive disease;
Cachexia;
Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;
Anticipated to undergo other surgical or interventional procedures within 6 months;
Life expectancy <12 months;
Allergy to the drugs or metal materials used in the study;
Women who are breastfeeding, pregnant, or planning to become pregnant within one year;
Participation in another drug or medical device clinical trial within 3 months prior to screening;
Any condition deemed unsuitable for participation in this clinical trial by the investigator. \|

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Interventions

DEVICEPercutaneous 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

DRUGControl group (receiving standard medical therapy alone)

Control group (receiving standard medical therapy alone)