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Идёт набор NCT07662655

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

Ранняя фаза I С лечением Pulmonary Hypertension Pulmonary Hypertension Associated With HFpEF

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Percutaneous Pulmonary Artery Denervation (PADN), Control group (receiving standard medical therapy alone).
Кому может быть актуально
Состояния в реестре: Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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

Вмешательства

  • Устройство 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PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the
  • Препарат Control group (receiving standard medical therapy alone)
    Control group (receiving standard medical therapy alone)

Первичные конечные точки

  • Clinical worsening event [Срок оценки: From enrollment up to 12 months]
Вторичные конечные точки (12)
  • Changes from baseline in pulmonary vascular resistance (right heart catheterization) [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in echocardiographic linear dimension parameters [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in echocardiographic percentage functional indices [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in cardiac output (right heart catheterization) [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in WHO functional class [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in NT-proBNP/BNP [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in 6-minute walk distance (6MWD) [Срок оценки: From enrollment up to 12 months]
  • Changes from baseline in Short Form-36 (SF-36) Health Survey scale score [Срок оценки: From enrollment up to 12 months]
  • All-cause rehospitalization rate [Срок оценки: From enrollment up to 12 months]
  • Incidence of worsening heart failure symptoms requiring intravenous therapy [Срок оценки: From enrollment up to 12 months]
  • Heart failure-related rehospitalization rate [Срок оценки: From enrollment up to 12 months]
  • Rate of need for heart/lung transplantation [Срок оценки: From enrollment up to 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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;
  • Cachexia;
  • 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. \|

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Structural Heart Disease Unit, Xiamen Cardiovacular Hospital — Xiamen

Идентификаторы

NCT: NCT07662655 · 2026KY001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗