Pulmonary Arteyr Denervation for Heart Failure - Trial NCT06323512

Timeline & Enrollment

Primary Outcome

Left ventricular ejection fraction,Tricuspid annuls peak systolic excursion (TAPSE),6 minute walk distance changes

Summary

Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean
 pulmonary arterial pressure 20 mmHg and pulmonary artery wedge pressure 15 mmHg at rest,
 as determined by right heart catheterization. Pulmonary hypertension secondary to heart
 failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension
 (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and
 post-capillary pulmonary hypertension (Cpc-PH, PVR 2 Woods Unit), the later reflecting
 additional pulmonary vascular constriction or remodeling in addition to passive PH. While
 medications tailored for World Health Organization defined Group I pulmonary arterial
 hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of
 pulmonary hypertension exacerbates the severity of heart failure. Given the presence of
 pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients
 with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary
 artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left
 ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left
 atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the
 feasibility, safety, and efficacy of PADN for patients with heart failure independent of left
 ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with
 HFrEF and another 15 with HFpEF).

ICD-10 Classifications