NCT04592445

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction: Randomized Controlled Feasibility Trial - The Rebalance HF Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Axon Therapies, Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.

Detailed description

Up to 150 people will take part in this clinical study. Phase I of the REBALANCE-HF Study The first part of the study took place between January 2021 and March 2023. During this phase, 116 patients participated. Researchers reviewed the results to learn whether the procedure appeared safe and whether it might help improve symptoms in people with heart failure with preserved ejection fraction (HFpEF). This early review showed encouraging results in some patients. It also helped researchers identify a group of patients who seemed more likely to benefit from the procedure. Phase II of the REBALANCE-HF Study: The current phase of the study focuses on patients who have similar characteristics to those who responded well in Phase I. The goal is to confirm whether this group of patients may benefit most from the treatment and whether the procedure should be studied further in a larger future trial. This study will take place at multiple hospitals and research centers. Participants who qualify for the study will be randomly assigned to one of two groups: * Treatment group: The procedure is performed using the Satera Ablation System to treat a nerve called the greater splanchnic nerve. * Control (sham) group: A simulated procedure is performed, but the treatment itself is not delivered. Participants will be assigned to a group by chance, similar to flipping a coin, although twice as many patients will receive the treatment as the sham procedure (2:1 ratio). The group assignment will happen during the procedure after anesthesia is given, and only after the doctor confirms that the patient's anatomy is suitable for the procedure. Blinding: To make sure the results are fair and unbiased: * Participants and their heart failure doctors will not know whether the patient received the treatment or the sham procedure. * The doctor performing the procedure and certain study staff will know which procedure is performed so they can carry out the procedure safely. * The study safety team will also know this information to help monitor patient safety. Sham Procedure: A sham procedure is used to help researchers understand whether any improvements are due to the treatment itself or to the placebo effect. During the sham procedure: A small needle puncture is made in the groin or neck, similar to what is done for many heart procedures. Doctors check the veins to confirm whether the procedure could have been performed. However, the treatment catheter is not used and the nerve is not treated. The sham procedure takes about 45 minutes, which is about the same amount of time as the treatment procedure. Number of Participants: 90 patients were assigned to treatment or sham during Phase I. In Phase II, up to 60 additional patients will be enrolled. About 40 patients will receive the treatment, and about 20 will receive the sham procedure.

Conditions

• Heart Failure With Preserved Ejection Fraction (HFpEF

Interventions

Type	Name	Description
DEVICE	Greater Splanchnic Nerve Ablation	The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat.
DEVICE	Sham Control	During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure.

Timeline

• Start date: 2020-12-18
• Primary completion: 2028-01-10
• Completion: 2029-08-10
• First posted: 2020-10-19
• Last updated: 2026-03-13

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated device study