Could zapping nerves in lung arteries ease pressure after heart valve surgery?
NCT ID NCT07662655
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure called pulmonary artery denervation (PADN) for people who still have high blood pressure in their lung arteries after a mitral valve repair. The procedure uses a catheter to deliver radiofrequency energy to specific nerve points in the main pulmonary artery, aiming to lower pressure and improve symptoms. Researchers will compare PADN plus standard medical therapy to standard therapy alone in 60 adults aged 18 to 80, tracking heart failure events and changes in lung artery resistance over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Percutaneous pulmonary artery denervation (PADN) catheter device
- What this could lead to
- If successful, this procedure could offer a new way to manage pulmonary hypertension after mitral valve repair, potentially reducing hospitalizations and improving heart function.
- What could go wrong
- This is an early-phase trial with only 60 participants, so results may not apply broadly. The procedure carries risks such as bleeding, arrhythmia, or vessel damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. \|
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
RECRUITINGXiamen, Fujian, 361000, China
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