Chronic heart failure (CHF) patients who have received guideline-directed medical therapy (GDMT) based on the 2022 American Heart Association (AHA)/American College of Cardiology (ACC) Guidelines for HF and have reached clinical stable, and diagnosed with PH-LHD by right heart catheterization, will be randomized to the PADN group or control group in a 1:1 ratio to receive PADN combined with HF GDMT or HF GDMT, respectively. After the primary endpoint follow-up is completed at the 6-months visit, participants in the control group who still meet the inclusion and exclusion criteria can also choose to receive PADN.~Approximately 276 participants will be enrolled at up to 28 centers in China and followed for 3 years. The safety and efficacy of the PADN system, including RF ablation catheter and generator will be evaluated by comparing the therapeutic effect of the PADN group and the control group.
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.