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Hypertension / Pulmonary Artery Denervation (PADN) / Sham procedure control · Interventional Study
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned randomized controlled trial comparing percutaneous pulmonary artery denervation (PADN) via the Enhancor System to sham procedure in patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease. The study is currently recruiting and has not yet reported results; efficacy and safety outcomes will be assessed at 12 months and 30 days respectively, with 3-year follow-up planned.
Interventional, Randomized, Parallel, Double masking, Treatment purpose. Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure, Heart Failure Wi…; age from 18 Years; to 85 Years. Intervention: Pulmonary Artery Denervation (PADN). Compared with: Control — Active Comparator. n = 750. 6 sites: United States.
This is a planned randomized controlled trial comparing percutaneous pulmonary artery denervation (PADN) via the Enhancor System to sham procedure in patients with combined pre- and post-capillary pulmonary hypertension due to left heart disease. The study is currently recruiting and has not yet reported results; efficacy and safety outcomes will be assessed at 12 months and 30 days respectively, with 3-year follow-up planned.
This is a registry record with no results posted; no efficacy or safety data are yet available for clinical decision-making.
The source did not state who this applies to in practice.
This is a clinical trial registry record describing a planned interventional study with no posted results; enrollment is ongoing and efficacy/safety data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07214376). This is a study registration, not published results. Lead sponsor: Pulnovo Medical, Inc.. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 750 participants (ESTIMATED). Conditions: Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Hypertension, Vascular Diseases, Cardiovascular Diseases, Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction. Interventions: DEVICE: Pulmonary Artery Denervation (PADN); DEVICE: Sham procedure control. Primary outcome measures: Primary Efficacy Endpoint , Immediately after the randomization to last enrolled patient reaches 12-month follow-up; Primary Safety Endpoint , 30-days. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.