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

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; Pulmonary Hypertension Associated With HFpEF
• Intervention / Treatment: Device: Percutaneous Pulmonary Artery Denervation (PADN); Drug: Control group (receiving standard medical therapy alone)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Xiang CHEN, Dr; Phone Number: +8618033997788; Email: seanchenx@126.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
      • Contact: Xiang Chen; Phone Number: 18033997788; Email: seanchenx@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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. |

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PADN group (receiving PADN plus standard medical therapy)	Device: Percutaneous Pulmonary Artery Denervation (PADN); **PADN Procedure Steps:**; Non-Selective Pulmonary Artery Angiography; PADN Ablation Target Selection; Hemodynamic Assessment; Establishment of the PADN® RF Catheter Delivery Rail; PADN® RF Catheter Delivery; 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.; Completion of the PADN
Placebo Comparator: Control group (receiving standard medical therapy alone)	Drug: Control group (receiving standard medical therapy alone); Control group (receiving standard medical therapy alone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical worsening event	defined as the occurrence of any of the following: Worsening heart failure symptoms requiring intravenous therapy (inotropes, diuretics, or vasodilators);; Heart failure-related rehospitalization;; Decrease in 6MWD from baseline by >10% or >30 meters;; Need for heart/lung transplantation;; All-cause death	From enrollment up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in pulmonary vascular resistance (right heart catheterization)	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	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	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)	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		From enrollment up to 12 months
Changes from baseline in NT-proBNP/BNP		From enrollment up to 12 months
Changes from baseline in 6-minute walk distance (6MWD)		From enrollment up to 12 months
Changes from baseline in Short Form-36 (SF-36) Health Survey scale score	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		From enrollment up to 12 months
Incidence of worsening heart failure symptoms requiring intravenous therapy		From enrollment up to 12 months
Heart failure-related rehospitalization rate		From enrollment up to 12 months
Rate of need for heart/lung transplantation		From enrollment up to 12 months
Changes from baseline in intracardiac pressure parameters (right heart catheterization)	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)	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)	Parameter: Pulmonary arterial compliance (PAC); Unit of measure: milliliters per millimeter of mercury (mL/mmHg)	From enrollment up to 12 months

Collaborators and Investigators

• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2026KY001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No