NCT07662655

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
25mo left

Started Jun 2026

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Aug 2028

First Submitted

Initial submission to the registry

May 2, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

May 2, 2026

Last Update Submit

June 17, 2026

Conditions

Pulmonary HypertensionPulmonary Hypertension Associated With HFpEF

Outcome Measures

Primary Outcomes (1)

  • Clinical worsening event

    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

Secondary Outcomes (15)

  • Changes from baseline in pulmonary vascular resistance (right heart catheterization)

    From enrollment up to 12 months

  • Changes from baseline in echocardiographic linear dimension parameters

    From enrollment up to 12 months

  • Changes from baseline in echocardiographic percentage functional indices

    From enrollment up to 12 months

  • Changes from baseline in cardiac output (right heart catheterization)

    From enrollment up to 12 months

  • Changes from baseline in WHO functional class

    From enrollment up to 12 months

  • +10 more secondary outcomes

Study Arms (2)

PADN group (receiving PADN plus standard medical therapy)

EXPERIMENTAL

PADN group (receiving PADN plus standard medical therapy)

Device: Percutaneous Pulmonary Artery Denervation (PADN)

Control group (receiving standard medical therapy alone)

PLACEBO COMPARATOR

Control group (receiving standard medical therapy alone)

Drug: Control group (receiving standard medical therapy alone)

Interventions

Percutaneous Pulmonary Artery Denervation (PADN)DEVICE

\*\*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

PADN group (receiving PADN plus standard medical therapy)
Control group (receiving standard medical therapy alone)DRUG

Control group (receiving standard medical therapy alone)

Control group (receiving standard medical therapy alone)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Structural Heart Disease Unit, Xiamen Cardiovacular Hospital

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Xiang CHEN, Dr

CONTACT

+8618033997788seanchenx@126.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2026

First Posted

June 23, 2026

Study Start

June 6, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Locations

CN(1)