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Recruiting 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

Early Phase I Interventional Pulmonary Hypertension Pulmonary Hypertension Associated With HFpEF

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous Pulmonary Artery Denervation (PADN), Control group (receiving standard medical therapy alone).
Who it may be relevant to
Registry conditions: Pulmonary Hypertension, Pulmonary Hypertension Associated With HFpEF. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

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PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the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

Primary outcome measures

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

Eligibility criteria

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;
  • 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. \|

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Structural Heart Disease Unit, Xiamen Cardiovacular Hospital — Xiamen

Identifiers

NCT: NCT07662655 · 2026KY001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗