Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
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
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
Treatments tested in this trial
- Right Greater Splanchnic Nerve (GSN) ablation
- Sham Control
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov