NCT07662655RecruitingPhase 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
Xiamen Cardiovascular Hospital, Xiamen University1 site in 1 country60 target enrollmentStarted: June 6, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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;
- •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. |
Investigators
Xiang Chen
Principal Investigator
Xiamen Cardiovascular Hospital, Xiamen University
Study Sites (1)
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