PADN-PH-LHD
A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of Single-use Ring-shaped Pulmonary Artery Radiofrequency Ablation Catheter and Pulmonary Artery RF Ablation Generator for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Patient / Population Intervention / Exposure Comparison Outcome
In 264 patients with pulmonary hypertension due to heart failure, pulmonary artery denervation was compared with medical therapy alone on clinical worsening.
N
264
Design
phase 3 device trial, prospective, multicentre (up to 39 centres in China), randomised 1:1, open-label with blinded outcome assessment; pulmonary artery denervation plus guideline-directed medical therapy vs guideline-directed medical therapy alone (no sham procedure); primary analysis when the last enrolled patient reaches 6 months; follow-up to 3 years; control patients may cross over to PADN at 12 months
Endpoint
Clinical worsening — first occurrence of any of: intravenous inotropes, diuretics or vasodilators for worsening heart failure; rehospitalisation for heart failure; 6-minute walk distance decrease >10 % or >30 m from baseline; referral for heart or heart–lung transplantation; all-cause death — assessed when the last enrolled patient has ≥6 months of follow-up