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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 juni 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000
        • Werving
        • Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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. |

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: PADN group (receiving PADN plus standard medical therapy)
Apparaat: 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
Placebo-vergelijker: Control group (receiving standard medical therapy alone)
Geneesmiddel: Control group (receiving standard medical therapy alone)
Control group (receiving standard medical therapy alone)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinical worsening event
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 juni 2026

Primaire voltooiing (Geschat)

31 mei 2028

Studie voltooiing (Geschat)

31 augustus 2028

Studieregistratiedata

Eerst ingediend

2 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026KY001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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