A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease

Inclusion criteria

• ✓. Subject is ≥18 and ≤85 years of age
• ✓. Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as appropriate per US or EU guidelines according to region of enrollment
• ✓. Subject is clinically stable, defined as:
• ✓. PASP (RVSP) is ≥30 mmHg on the baseline TTE.
• ✓. Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).
• ✓. Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues
• ✓. Subject has NT-proBNP ≥600 pg/mL for patients with LVEF ≤40% or ≥200 pg/mL for patients with LVEF \>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)
• ✓. Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing.

Exclusion criteria