IRB Study Number 26-135
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Pulmonary hypertension caused by left-sided heart disease is a condition in which problems with your heart’s pumping ability cause increased blood pressure in the lungs. Patients with this condition are very symptomatic and are at high risk for death and frequent hospitalization. Currently, no specific approved treatments exist for this condition. The objective of this study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD).
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:
o No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure
o SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)
Exclusion Criteria
Subject has a life expectancy of less than 1 year due to non-cardiovascular causes
Subject has known hypertrophic cardiomyopathy with either left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM) of the anterior leaflet of the mitral valve; pericardial disease; or infiltrative or active inflammatory myocardial disease, including known amyloidosis
Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve
