Condition: Pulmonary Hypertension · Heart Failure With Reduced Ejection Fraction · Hypertension · Sponsor: Pulnovo Medical, Inc.
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.
This description comes directly from the study's public registry record.
MOFFETT LAURA MARY GINTANT · +1 952 303 2821 · laura.moffett@pulnovomed.com
Mark Gu · +08 13774217349 · mark.g@pulnovomed.com
Always discuss trial participation with your own doctor first.
| Cardiovascular Institute of the South | Houma, Louisiana, United States | Recruiting |
| Oklahoma Heart Institute | Tulsa, Oklahoma, United States | Recruiting |
| University of Pittsburgh Medical Center | Mechanicsburg, Pennsylvania, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07214376