NCT07403058

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction

Endovascular Ablation Of The Right Greater Splanchnic Nerve In Subjects Having Heart Failure With Reduced Ejection Fraction: Randomized Controlled Feasibility Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Axon Therapies, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study is a small, early-stage clinical trial designed to test whether a new catheter-based procedure is safe and may help people with heart failure with reduced ejection fraction (HFrEF). The procedure uses the Satera Ablation System to treat the right greater splanchnic nerve, which may play a role in heart failure symptoms. The study also aims to identify which types of patients might benefit most from this treatment in the future. Up to 50 patients aged 40 or older with HFrEF will take part at as many as 10 hospitals worldwide. The study is prospective, meaning patients are followed forward in time, and it is randomized, double-blinded, and sham-controlled. Patients are randomly assigned in a 2:1 ratio to either receive the actual nerve ablation treatment or a sham (placebo) procedure. Randomization happens during the procedure, after anesthesia or sedation, to reduce the risk of revealing which treatment the patient receives. Neither the patient nor their heart failure doctor will know whether the patient received the real treatment or the sham. However, the doctor performing the procedure and certain study staff will know, mainly for safety and operational reasons. The sham procedure is designed to mimic the real procedure as closely as possible without performing the nerve ablation. It involves placing a small needle in the groin or neck and accessing the vein, but no treatment catheter is inserted. The sham procedure takes about the same amount of time as the real treatment (around 45 minutes) to help account for any placebo effect. Overall, this study is focused on evaluating safety and early signs of benefit rather than proving long-term effectiveness.

Conditions

• Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

Type	Name	Description
DEVICE	Right Greater Splanchnic Nerve (GSN) ablation	Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.
PROCEDURE	Sham Control	Simulated procedure designed to mimic the treatment experience without delivering nerve ablation

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-09-01
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

6 sites across 4 countries: Czechia, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study