Pulmonary Artery Denervation for Pulmonary Hypertension After M-TEER

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective cohort study evaluating the safety and feasibility of Percutaneous Pulmonary Artery Denervation (PADN) in patients who developed pulmonary hypertension after successful M-TEER. Participants are adults 18–80 who have persistent PH after at least 3 months on guideline-directed medical therapy. The PADN group will receive the denervation procedure in addition to standard therapy, while the control group receives standard medical therapy alone, with follow-up to assess clinical outcomes and safety. The study aims to provide evidence to guide treatment decisions in this specific post-M-TEER PH population.

Why it matters

Who can join: the full rules

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. \|

Where it's running

• Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
  Xiamen, Fujian, China Recruiting

Study contacts

• Study coordinator: Xiang CHEN, Dr
• Email: seanchenx@126.com
• Phone: +8618033997788

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.