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

ConditionHeart Failure With Reduced Ejection Fraction (HFrEF)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorAxon Therapies, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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).

Disqualifiers

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.

ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.

Inotropic infusion (continuous or intermittent) within 6 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

Right Greater Splanchnic Nerve (GSN) ablation
Device
Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.
Sham Control
Procedure/Surgery
Simulated procedure designed to mimic the treatment experience without delivering nerve ablation

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Greater Splanchnic Nerve AblationExperimental treatment 1 intervention

Group B: Sham treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

Device or procedure related serious adverse events

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

Time frame

Treatment through the 1 month

NT-proBNP (6 months)

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

Time frame

Baseline through the 6 months

Secondary outcomes

Serious device related cardiac or vascular events

Incidence of serious device related cardiac or vascular events for up to 12 months

Time frame

Treatment through the 12 months

Device or procedure related pain

Device or procedure related pain lasting at least 30 days and requiring medical management

Time frame

Enrollment through the 12 months

Orthostatic hypotension

Incidence of new orthostatic hypotension up to 12 months

Time frame

Procedure through 12 months

Acute Kidney Injury

Incidence of AKI requiring renal replacement therapy up to 12 months

Time frame

Procedure through 12 months

Other outcomes

Diuretic Dose

Change in diuretic dose through 6 and 12 months

Time frame

Baseline through 6- and 12 months

High Sensitivity C-reactive Protein

Change in high sensitivity C-reactive protein levels from baseline through 6 and 12 months

Time frame

Baseline through 6- and 12 months

Weight

Change in weight from baseline through 6 and 12 months

Time frame

Baseline through 6- and 12 months

HbA1c

Change in HbA1c from baseline through 6 and 12 months

Time frame

Baseline through 6- and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Axon Therapies, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: