RecruitingEarly Phase 1NCT07662655

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

Sponsor

Xiamen Cardiovascular Hospital, Xiamen University

Enrollment

60 participants

Start Date

Jun 6, 2026

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Pulmonary Hypertension Associated With HFpEF

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

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Control group (receiving standard medical therapy alone) and a medical device called Percutaneous Pulmonary Artery Denervation (PADN) for people with pulmonary hypertension and pulmonary hypertension associated with hfpef. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPercutaneous 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PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A,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

DRUGControl group (receiving standard medical therapy alone)

Control group (receiving standard medical therapy alone)