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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

17 de junio de 2026 actualizado por: Xiang Chen, Xiamen Cardiovascular Hospital, Xiamen University
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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase temprana 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Xiang CHEN, Dr
  • Número de teléfono: +8618033997788
  • Correo electrónico: seanchenx@126.com

Ubicaciones de estudio

  • Porcelana
    • Fujian
      • Xiamen, Fujian, Porcelana, 361000
        • Reclutamiento
        • Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
        • Contacto:
          • Xiang Chen
          • Número de teléfono: 18033997788
          • Correo electrónico: seanchenx@126.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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. |

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: PADN group (receiving PADN plus standard medical therapy)
Dispositivo: Percutaneous Pulmonary Artery Denervation (PADN)

**PADN Procedure Steps:**

  1. Non-Selective Pulmonary Artery Angiography
  2. PADN Ablation Target Selection
  3. Hemodynamic Assessment
  4. Establishment of the PADN® RF Catheter Delivery Rail
  5. PADN® RF Catheter Delivery
  6. Performance of the PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A, B, and C. . Temperature-controlled mode is recommended for radiofrequency ablation, with the ablation temperature set to 50°C and the total ablation time set to 150 seconds. The pulmonary artery radiofrequency ablation generator will automatically start calculating the effective ablation time (ET) once the ablation temperature reaches 45°C. Ablation at each target point is considered effective when the ET reaches at least 120 seconds.
  7. Completion of the PADN
Comparador de placebos: Control group (receiving standard medical therapy alone)
Droga: Control group (receiving standard medical therapy alone)
Control group (receiving standard medical therapy alone)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical worsening event
Periodo de tiempo: From enrollment up to 12 months

defined as the occurrence of any of the following:

  1. Worsening heart failure symptoms requiring intravenous therapy (inotropes, diuretics, or vasodilators);
  2. Heart failure-related rehospitalization;
  3. Decrease in 6MWD from baseline by >10% or >30 meters;
  4. Need for heart/lung transplantation;
  5. All-cause death
From enrollment up to 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes from baseline in pulmonary vascular resistance (right heart catheterization)
Periodo de tiempo: From enrollment up to 12 months
Changes from baseline in pulmonary vascular resistance (PVR); Unit of measure: Wood units
From enrollment up to 12 months
Changes from baseline in echocardiographic linear dimension parameters
Periodo de tiempo: From enrollment up to 12 months
Changes from baseline in right atrial diameter (RAD), left atrial diameter (LAD), left ventricular internal diameter at end-diastole (LVIDd), left ventricular posterior wall thickness at end-systole (LVPWd), and tricuspid annular plane systolic excursion (TAPSE); Unit of measure: millimeters (mm)
From enrollment up to 12 months
Changes from baseline in echocardiographic percentage functional indices
Periodo de tiempo: From enrollment up to 12 months
  • Parameters: Ejection fraction (EF), right ventricular fractional area change (RV-FAC)
  • Unit of measure: percentage (%)
From enrollment up to 12 months
Changes from baseline in cardiac output (right heart catheterization)
Periodo de tiempo: From enrollment up to 12 months
  • Parameter: Cardiac output (CO)
  • Unit of measure: liters per minute (L/min)
From enrollment up to 12 months
Changes from baseline in WHO functional class
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in NT-proBNP/BNP
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in 6-minute walk distance (6MWD)
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in Short Form-36 (SF-36) Health Survey scale score
Periodo de tiempo: From enrollment up to 12 months
The SF-36 scale ranges from 0 to 100, where higher scores indicate a better outcome (Minimum = 0, Maximum = 100).
From enrollment up to 12 months
All-cause rehospitalization rate
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Incidence of worsening heart failure symptoms requiring intravenous therapy
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Heart failure-related rehospitalization rate
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Rate of need for heart/lung transplantation
Periodo de tiempo: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in intracardiac pressure parameters (right heart catheterization)
Periodo de tiempo: From enrollment up to 12 months
  • Parameters: mean right atrial pressure (mRAP), right ventricular systolic pressure (RVSP), pulmonary artery systolic pressure (PASP), pulmonary artery diastolic pressure (PADP), mean pulmonary artery pressure (mPAP), pulmonary artery wedge pressure (PAWP)
  • Unit of measure: millimeters of mercury (mmHg)
From enrollment up to 12 months
Changes from baseline in cardiac index (right heart catheterization)
Periodo de tiempo: From enrollment up to 12 months
  • Parameter: Cardiac index (CI)
  • Unit of measure: liters per minute per square meter (L/min/m²)
From enrollment up to 12 months
Changes from baseline in pulmonary arterial compliance (right heart catheterization)
Periodo de tiempo: From enrollment up to 12 months
  • Parameter: Pulmonary arterial compliance (PAC)
  • Unit of measure: milliliters per millimeter of mercury (mL/mmHg)
From enrollment up to 12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Xiamen Cardiovascular Hospital, Xiamen University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de junio de 2026

Finalización primaria (Estimado)

31 de mayo de 2028

Finalización del estudio (Estimado)

31 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

2 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2026

Publicado por primera vez (Actual)

23 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026KY001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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