An upcoming clinical trial aims to assess the safety and efficacy of Pulmonary Artery Denervation (PADN) for patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease. Sponsored by Pulnovo Medical, Inc., this randomized, placebo-procedure-controlled study represents a significant development in addressing severe cardiovascular conditions. The study is not yet recruiting as of October 9, 2025.
In this article:
- What is the purpose of the trial?
- How is the study designed?
- Who qualifies for this trial?
- FAQ
- What are the next steps?
- Disclaimer
- For more information
What is the purpose of the trial?
This trial is designed to evaluate the PADN system, a medical device intended to treat patients affected by complex pulmonary hypertension tied to left heart disease. Conditions under investigation include heart failure with reduced, preserved, and mid-range ejection fractions, among others. Investigators aim to generate high-quality evidence regarding the safety profile and therapeutic potential of the technology.
How is the study designed?
The trial employs a randomized, controlled design to ensure robust and unbiased results. Patients will be allocated to one of two groups: an active treatment group receiving PADN therapy or a control group undergoing a sham procedure. This design aims to isolate the true efficacy of the PADN system while mitigating placebo effects.
What interventions are included?
The intervention arm will involve the PADN system, which targets abnormal signaling in the pulmonary arteries to potentially improve hemodynamic parameters. The sham control group will simulate the procedure for comparator purposes but will not deliver therapeutic effects. This dual-group approach strengthens the study's validity.
Who qualifies for this trial?
The eligibility criteria will focus on patients diagnosed with combined pre- and post-capillary pulmonary hypertension associated with left heart disease. Additional subcategories include conditions like hypertension, cardiovascular diseases, and various forms of heart failure.
Specific inclusion and exclusion criteria will be disclosed to ensure patient safety and relevance to the study objectives. Interested parties should monitor updates on the trial's recruitment status.
FAQ
1. What is pulmonary artery denervation?
Pulmonary artery denervation is a minimally invasive procedure designed to address excessive nerve activity in the pulmonary arteries. It aims to improve heart function and reduce pulmonary vascular resistance.
2. When will the trial begin recruiting?
The study is not yet recruiting as of October 9, 2025. Further updates will be provided on the official ClinicalTrials.gov page.
3. How can I learn more about participation criteria?
Eligibility details can be found through the ClinicalTrials.gov listing or by contacting the sponsor, Pulnovo Medical, Inc., directly.
What are the next steps?
The upcoming trial represents a critical milestone in expanding treatment options for patients with pulmonary hypertension linked to left heart disease. Researchers and clinical practitioners should continue monitoring developments. Individuals affiliated with regulatory affairs, quality assurance, and clinical research are encouraged to engage with the study once recruitment begins.
Disclaimer
This article is intended for informational purposes only and should not be interpreted as legal or professional medical advice. Refer to regulatory and clinical guidelines for detailed recommendations.
For more information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07214376?term=medical+device