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
Sponsor: Pulnovo Medical, Inc. • ClinicalTrials.gov ID: NCT07214376
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The goal of this clinical 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). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.
Interventions
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Pulmonary Artery Denervation (PADN)
(Device)
In patients randomized to Intervention, a Contrast pulmonary artery (PA) angiography will be performed to identify the pulmonary artery bifurcation and measure the PA diameter. Once the anatomy is deemed suitable, a radiofrequency ablation catheter will be introduced into the ostium of the left PA and the distal bifurcation of the main PA. The catheter will be maneuvered within the PA to deliver energy circumferentially, ensuring tight electrode contact with the endovascular surface. Approximately three ablations will be performed at a target temperature of 50 °C (range 45-55 °C) for 120 seconds each at both the left PA ostium and the distal main PA bifurcation. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)
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Sham procedure control
(Device)
In patients randomized to a placebo-procedure, a script will be followed for approximately 20 minutes to simulate the PADN procedure. All patients enrolled in this clinical study will following the Guideline-Directed Medical Therapy (GDMT)
Eligibility criteria
Conditions
Locations
- Banner - University Medical Center Tucson — Tucson, Arizona, United States
- Yale University — New Haven, Connecticut, United States
- Cleveland Clinic Florida - Weston — Weston, Florida, United States
- Cardiovascular Institute of the South — Houma, Louisiana, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- North Shore University Hospital — Manhasset, New York, United States
- Mount Sinai Morningside — New York, New York, United States
- NewYork-Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States
- Weill Cornell Medical Center — New York, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Oklahoma Heart Institute — Tulsa, Oklahoma, United States
- University of Pittsburgh Medical Center — Mechanicsburg, Pennsylvania, United States
- Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
- Xiamen Cardiovascular Hospital Xiamen University — Xiamen, Fujian, China
- Nanjing First Hospital — Nanjing, Jiangsu, China
- Qilu Hospital of Shandong University — Jinan, Shandong, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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