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

Recruiting now · Early Phase 1

Conditions studied: Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF

In brief

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

Key facts

Study ID

NCT07662655

Run by

Xiamen Cardiovascular Hospital, Xiamen University

People needed

60

Starts

2026-06-06

Expected to finish

2028-08-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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. \|

Where it is running

• Structural Heart Disease Unit, Xiamen Cardiovacular Hospital — Xiamen, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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