A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency (RF) Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.
• Age ≥18, ≤75 years old;
• Diagnosed with chronic heart failure for at least 3 months, and have received the GDMT pharmacological treatment based on the 2023 ESC Guidelines for Heart Failure for at least 1 month;
• Clinically stable defined by
‣ No intravenous diuretics, inotropes or vasodilators for at least 1 month, and
⁃ Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg and resting heart rate (HR) ≥50 and \<100 bpm (\<110 bpm for atrial fibrillation) on the day of the procedure
• New York Heart Association (NYHA) class II-IVa;
• 6MWD ≥ 100 m and \< 450 m;
• NT-proBNP \> 125 pg/mL (BNP \> 35 pg/mL);
• Hemodynamic indicators (RHC) :
‣ Mean pulmonary arterial pressure (mPAP) \> 20 mmHg
⁃ Pulmonary capillary wedge pressure (PCWP) \>15 mmHg
• Understand and be willing to sign informed consent, and be willing to follow the follow-up plan required by the protocol.