Actively Recruiting
Study of the Enhancor System for Pulmonary Artery Denervation to Treat Pulmonary Hypertension in Patients with Left Heart Disease
Led by Pulnovo Medical, Inc. · Updated on 2026-07-07
750
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is studying patients with combined pre- and post-capillary pulmonary hypertension CpcPH linked to left heart disease LHD. It aims to evaluate the safety and effectiveness of a new device called the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System, compared to standard medical therapy. The study includes patients with chronic heart failure who are stable and already receiving the best available medical treatments for left heart failure. Participants will be randomly assigned to one of two groups the intervention group will receive pulmonary artery denervation PADN using the Enhancor System plus guideline-directed medical therapy GDMT, while the control group will undergo a placebo procedure plus GDMT. Before randomization, some operators may perform up to two roll-in PADN procedures to gain experience. Participants will be followed for 3 years, with clinical assessments at 1, 6, 12, 24, and 36 months. Control subjects who experience a primary efficacy endpoint event may cross over to receive PADN after 24 months if eligible. During the study, participants will undergo various assessments including heart function tests, walking distance tests, biomarker blood tests NT-proBNP, and quality of life questionnaires Kansas City Cardiomyopathy Questionnaire at several time points. Safety will be monitored closely, especially within 30 days after the procedure. Researchers will track heart failure events, hospitalizations, device implantations, heart transplantations, and cardiovascular deaths over the 3 years. Participants are expected to comply with medication and follow-up visits throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Diagnosed with chronic heart failure due to left-sided heart disease for at least 6 months
- Symptomatic despite maximally tolerated guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy as appropriate
- Clinically stable with no heart failure hospitalizations or major medication changes for at least 1 month
- Resting systolic blood pressure between 90 and 160 mmHg and resting heart rate between 50 and 100 bpm (up to 110 bpm if atrial fibrillation)
- Pulmonary artery systolic pressure (PASP) of at least 30 mmHg by echocardiogram
- New York Heart Association (NYHA) class II, III or IVa symptoms
- 6-minute walk distance between 100 and 450 meters limited by breathlessness or fatigue
- NT-proBNP levels ≥600 pg/mL for LVEF ≤40% or ≥200 pg/mL for LVEF >40%
- Able and willing to comply with study protocol including medication and follow-up visits
- Signed informed consent form
You will not qualify if you...
- Life expectancy less than 1 year due to non-cardiovascular causes
- Known hypertrophic cardiomyopathy with outflow obstruction or systolic anterior motion, pericardial disease, or infiltrative/inflammatory myocardial disease
- Severe stenosis or regurgitation of any heart valve or moderate/severe aortic valve stenosis
- Recent symptomatic carotid stenosis, stroke, or transient ischemic attack
- Prior intracranial hemorrhage or intracranial pathology predisposing to bleeding
- Known bleeding disorders or refusal of blood transfusions
- Allergy to heparin unless alternatives can be used
- Life-threatening contrast dye allergy
- Congenital heart disease other than mitral valve prolapse or patent foramen ovale
- Recent or planned coronary artery bypass or percutaneous coronary intervention
- Recent or planned pacemaker or cardiac device implantation
- Recent or planned atrial fibrillation ablation
- Recent or planned heart valve surgery or intervention
- Tricuspid or pulmonic valve implants
- Inferior vena cava filter implant
- Prior heart or heart-lung transplant or planned ventricular assist device implant
- Intracardiac thrombus or significant pericardial effusion
- Pulmonary hypertension due to other WHO groups than Group 2
- Recent or planned use of group 1 pulmonary arterial hypertension drugs
- Planned major surgery within 6 months
- Severe kidney or liver insufficiency
- Low platelet count
- Systemic inflammatory disease requiring long-term immunosuppressants
- Active infection requiring antibiotics
- Body mass index over 45 kg/m²
- Severe respiratory disease or untreated severe sleep apnea
- Recent pulmonary embolism or deep vein thrombosis
- Pregnancy, breastfeeding, or planning pregnancy within one year
- Participation in other investigational drug or device trials
- Severe frailty, substance abuse, or conditions impairing study compliance
- Member of vulnerable populations unable to provide informed consent
Research Team
M
MOFFETT LAURA MARY GINTANT
M
Mark Gu
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