A not yet recruiting trial tests a device driven approach to heart failure with reduced ejection fraction by targeting the right greater splanchnic nerve to modulate autonomic activity. This report summarizes the public record and regulatory context for the study sponsored by Axon Therapies, Inc. The trial uses a right greater splanchnic nerve ablation device and a sham control to evaluate safety and performance in patients with HFrEF.
What is this trial about
The study investigates endovascular ablation of the right greater splanchnic nerve. The goal is to support treatment development for heart failure with reduced ejection fraction. The approach represents an autonomic modulation strategy in this condition. A sham control is used in the design to compare safety signals and potential performance effects. The sponsor identified in public records is Axon Therapies, Inc., and the ClinicalTrials.gov entry is NCT07403058.
How is the trial designed
Participants would receive the right GSN ablation device or a sham procedure. The design emphasizes safety and performance in an investigational setting. Not yet recruiting status indicates that enrollment has not begun. The description comes from the public record on ClinicalTrials.gov.
Who may participate and what is the status
Not yet recruiting means enrollment has not started. The source text notes the condition of interest is heart failure with reduced ejection fraction. Specific inclusion criteria and enrollment details are not provided in the excerpt. Access to the ClinicalTrials.gov page will provide the official protocol terminology and any updates.
Sponsor context
Axon Therapies, Inc. is listed as the sponsor. In a regulatory sense the sponsor leads the study design, safety monitoring and reporting obligations for this device oriented investigation. The public record reflects an investigational study status with no results yet published.
Regulatory status and timeline
The not yet recruiting status signals that enrollment is pending and regulatory processes continue. Device based autonomic modulation for heart failure remains under regulatory scrutiny in cardiovascular research. Readers should monitor the ClinicalTrials.gov record for updates on recruitment and outcomes.
FAQ
1. What device is studied The right greater splanchnic nerve ablation device is the investigational therapy used in the trial.
2. What is the current status The record shows not yet recruiting.
3. Who sponsors the study Axon Therapies, Inc.
Conclusion
This article summarizes a not yet recruiting endovascular trial targeting the right greater splanchnic nerve for heart failure with reduced ejection fraction. The focus is on safety and performance within a regulated investigational framework. Stakeholders should await official updates from ClinicalTrials.gov and the sponsor.
Disclaimer
This article is intended for medical device professionals and regulators. It is not legal advice. Consult appropriate authorities for guidance on compliance and enforcement related to clinical trials and device submissions.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07403058?term=medical+device