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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 juin 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • Première phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Xiang CHEN, Dr
  • Numéro de téléphone: +8618033997788
  • E-mail: seanchenx@126.com

Lieux d'étude

  • Chine
    • Fujian
      • Xiamen, Fujian, Chine, 361000
        • Recrutement
        • Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: PADN group (receiving PADN plus standard medical therapy)
Dispositif: 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
Comparateur placebo: Control group (receiving standard medical therapy alone)
Médicament: Control group (receiving standard medical therapy alone)
Control group (receiving standard medical therapy alone)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Clinical worsening event
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes from baseline in pulmonary vascular resistance (right heart catheterization)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in NT-proBNP/BNP
Délai: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in 6-minute walk distance (6MWD)
Délai: 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
Délai: 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
Délai: From enrollment up to 12 months
From enrollment up to 12 months
Incidence of worsening heart failure symptoms requiring intravenous therapy
Délai: From enrollment up to 12 months
From enrollment up to 12 months
Heart failure-related rehospitalization rate
Délai: From enrollment up to 12 months
From enrollment up to 12 months
Rate of need for heart/lung transplantation
Délai: From enrollment up to 12 months
From enrollment up to 12 months
Changes from baseline in intracardiac pressure parameters (right heart catheterization)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Xiamen Cardiovascular Hospital, Xiamen University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

6 juin 2026

Achèvement primaire (Estimé)

31 mai 2028

Achèvement de l'étude (Estimé)

31 août 2028

Dates d'inscription aux études

Première soumission

2 mai 2026

Première soumission répondant aux critères de contrôle qualité

17 juin 2026

Première publication (Réel)

23 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026KY001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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