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

Conditions: Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: EARLY_PHASE1

Enrollment: 60

Sponsor: Xiamen Cardiovascular Hospital, Xiamen University

Location: Structural Heart Disease Unit, Xiamen Cardiovacular Hospital Xiamen Fujian

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 Criteria

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) \

Source: ClinicalTrials.gov (NCT07662655). StuddyBuddy aggregates publicly available trial information.