NCT07662655RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 2 May 2026
- Start date
- 6 Jun 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Xiamen Cardiovascular Hospital, Xiamen University
- NCT number
- NCT07662655
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 6 Jun 2026 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated to undergo other surgical or interventional procedures within 6 months;
- Participation in another drug or medical device clinical trial within 3 months prior to screening;
Other illness
- Cardiac index (CI) \< 1.5 L/min/m²;
- 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;
- Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;
- Allergy to the drugs or metal materials used in the study;
- Any condition deemed unsuitable for participation in this clinical trial by the investigator. \|
Lab values
- 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);
Other
- Cachexia;
- Life expectancy \<12 months;
- Women who are breastfeeding, pregnant, or planning to become pregnant within one year;
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Structural Heart Disease Unit, Xiamen Cardiovacular Hospital Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.