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

NCT07403058 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CP003
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 6

Brief 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)

Keywords

Heart Failure; Reduced Ejection Fraction; Right Greater Splanchnic Nerve (GSN)

Outcome Measures

Primary Outcomes (2)

• Device or procedure related serious adverse events

  Evaluation of device or procedure related serious adverse events based on Clinical Events Committee (CEC) assessment

  Treatment through the 1 month

• NT-proBNP (6 months)

  Assessment of change in NT-ProBNP from baseline to 6-month follow up visit

  Baseline through the 6 months

Secondary Outcomes (15)

• Serious device related cardiac or vascular events

  Treatment through the 12 months

• Device or procedure related pain

  Enrollment through the 12 months

• Orthostatic hypotension

  Procedure through 12 months

• Acute Kidney Injury

  Procedure through 12 months

• Worsening Glomerular Filtration Rate (GFR)

  Procedure through 12 months

Other Outcomes (14)

• Diuretic Dose

  Baseline through 6- and 12 months

• High Sensitivity C-reactive Protein

  Baseline through 6- and 12 months

• Weight

  Baseline through 6- and 12 months

Study Arms (2)

Greater Splanchnic Nerve Ablation

EXPERIMENTAL

Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) using the Satera Ablation System. Randomization occurs during the procedure after anesthesia or sedation and after confirmation that the subject's vein anatomy is suitable for treatment.

Device: Right Greater Splanchnic Nerve (GSN) ablation

Sham treatment

SHAM COMPARATOR

Subjects undergo a simulated procedure designed to mimic the treatment experience without delivering nerve ablation. This includes venous access via a small needle puncture in the groin or neck and assessment of vein anatomy, but no treatment catheter is inserted and no ablation is performed. The sham procedure lasts approximately the same amount of time as the active treatment.

Procedure: Sham Control

Interventions

Right Greater Splanchnic Nerve (GSN) ablation DEVICE

Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.

Greater Splanchnic Nerve Ablation

Sham Control PROCEDURE

Simulated procedure designed to mimic the treatment experience without delivering nerve ablation

Sham treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic heart failure, defined as:
• Symptoms of HF requiring current (QD or QOD or appropriate dosing as per screening committee) treatment with loop diuretics for at least 30 days prior to screening visit, AND
• NYHA class II, NYHA class III, or ambulatory NYHA class IV symptoms at screening or signs of HF, AND
• NT-proBNP \>800 pg/ml in normal sinus rhythm (\>1400 pg/ml in atrial fibrillation or flutter) within 3 months of consent, with no adjustment for BMI
• Ongoing stable GDMT HF management for a minimum of 30 days prior to screening (unless unable to tolerate GDMT) which refers to those HF drugs carrying a Class I indication, including:
• An inhibitor of the renin-angiotensin system (RAS inhibitor), including an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and beta-blocker (BB).
• A mineralocorticoid receptor antagonist (MRA), Sodium-Glucose Transport 2 inhibitor (SGLT2i), or nitrates/hydralazine, should be used in appropriate patients, according to the published guidelines unless intolerant or not indicated.
• Drug intolerance, contraindications, or lack of indications must be attested to by the investigator. Patients should be on appropriate doses of diuretics as required for volume control.
• Stable GDMT refers to consistent dose (change is considered a more than 100% increase or 50% decrease in dose) for at least 30 days prior to screening visit or as appropriate per the screening committee.
• Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.
• Considered for Class I recommended cardiac rhythm management device therapy. Specifically: if indicated by class I guidelines, cardiac resynchronization therapy (CRT), an implanted cardioverter- defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to enrollment. These criteria may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator.
• LVEF 20% - 40% (at screening visit and determined by echo core lab).
• Age ≥40 years.
• Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

You may not qualify if:

• MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.
• Cardiac resynchronization therapy initiated within 3 months prior to enrollment.
• Advanced heart failure defined as one or more of the following:
• ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
• Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
• Subject is on the cardiac transplant waiting list or has undergone transplant.
• Presence of, or history of, mechanical circulatory support for HF.
• Planned other advanced HF Therapies in the next 12 months.
• Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) \<12 mm or right ventricular (RV) fractional area change (FAC) \<25% (at screening visit and determined by echo core lab).
• Body mass index (BMI) \>45 kg/m2.
• minute walk test distance \<100 meters OR \>450 meters.
• Admission for HF within the 30 days prior to planned index procedure.
• Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of \>20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.
• Orthostatic pulse pressure narrowing from supine to standing (+3 minutes) of ≥10mmHg in the absence of a HR increase \>15bpm
• Postural orthostatic tachycardia syndrome or preload insufficiency syndrome or on medical therapy for neurogenic orthostatic hypotension (e.g., midodrine, droxidopa).

Sponsors & Collaborators

• Axon Therapies, Inc.: lead

Study Sites (6)

Motol and Homolka University Hospital

Prague, Czechia

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wrocławiu

Wroclaw, Poland

Location

Hospital Clínico Universitario de Valencia-INCLIVA

Valencia, Spain

Location

Vithas Valencia Turia

Valencia, Spain

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

King's College London

London, United Kingdom

Location

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Piotr Ponikowski, MD, PhD

  Professor of Cardiology, Head of the Department of Heart Diseases at Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Marat Fudim, MD, MHS

  Associate Professor of Medicine, Duke Clinical Research Institute of Cardiology

  PRINCIPAL INVESTIGATOR

• Klaus Witte, MD

  Senior Lecturer in Cardiology and Consultant Cardiologist Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds and Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judit Adorjan

CONTACT

+1 650 722-1119; j.adorjan@axontherapies.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, sham controlled, double blinded

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

CZ (1); PL (1); ES (2); GB (2)