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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiamen Cardiovascular Hospital, Xiamen University

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Percutaneous Pulmonary Artery Denervation (PADN)
  • Control group (receiving standard medical therapy alone)

Treatment groups

60 Participants
are divided into 2 treatment groups