Study for Evaluation of Safety and Efficacy of Pulmonary Artery Denervation to TreatCombined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure: a Pilot Study
The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure. Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.
• Age ≥18, ≤85 years;
• PH must be confirmed by RHC, defined as:
‣ Mean pulmonary arterial pressure (mPAP) \> 20mmHg, and;
⁃ Pulmonary capillary wedge pressure (PCWP) \>15mmHg.
• Chronic heart failure has been diagnosed at least 3 months before screening and have been treated on the GDMT according to 2022 AHA/ACC Guidelines for Heart Failure for at least 1 month;
• Clinically stable HF for at least 1 month, defined as:
‣ No need of intravenous diuretics, inotropes or vasodilators, and
⁃ Systolic blood pressure (SBP) ≥ 100 and \< 160 mmHg, and
⁃ Resting heart rate (HR) ≥ 50 bpm and \<100 bpm (\<110 bpm in presence of atrial fibrillation) on the day of the procedure.
• NYHA class II-IVa;
• 6MWD ≥ 100 m and ≤ 450 m;
• NT-proBNP \>125pg/mL (or BNP \> 35pg/mL);
• Understand and be willing to sign informed consent and be strictly willing to follow the protocol.