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
Study ID
NCT07662655
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Pulmonary Hypertension
  • Pulmonary Hypertension Associated With HFpEF

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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PADN Procedure While maintaining the transseptal sheath position unchanged, the PADN® RF catheter is gently and slowly withdrawn and rotated (either clockwise or counterclockwise) to bring any three of the No. 2-9 electrodes into close apposition with the three target ablation points A,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

Study Details

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

Key Dates

First listed
Jun 23, 2026
Start date
Jun 6, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PADN group (receiving PADN plus standard medical therapy)
    PADN group (receiving PADN plus standard medical therapy)
  • Placebo Comparator: Control group (receiving standard medical therapy alone)
    Control group (receiving standard medical therapy alone)

Primary Outcome Measure

Clinical worsening event [ Time Frame: From enrollment up to 12 months ]

Central Contacts

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