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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Subjects receive catheter-based unilateral ablation of the right greater splanchnic nerve.
Simulated procedure designed to mimic the treatment experience without delivering nerve ablation
Motol and Homolka University Hospital
Prague, Czechia
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wrocławiu
Wroclaw, Poland
Hospital Clínico Universitario de Valencia-INCLIVA
Valencia, Spain
Vithas Valencia Turia
Valencia, Spain
Leeds General Infirmary
Leeds, United Kingdom
King's College London
London, United Kingdom
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
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
Worsening Glomerular Filtration Rate (GFR)
Incidence of worsening GFR (defined as change \> 50% for at least 30 days in duration) up to 12 months
Time frame: Procedure through 12 months
Adverse Events
Incidence of all Adverse Events through 12 months
Time frame: Procedure through 12 months
Mortality
Incidence of all mortality for up to 12 months summarized as all-cause mortality, CV mortality, or heart failure-related
Time frame: Procedure through 12 months
Left Ventricular End Diastolic Volume (LVEDV)
Change in LVEDV from baseline indexed for body surface area (LVEDVi ml/m2) at 6 and 12 month follow up
Time frame: Baseline through 6- and 12- months
Left Ventricular Ejection Fraction (LVEF)
Change in LVEF from baseline at 6 and 12 month follow up
Time frame: Baseline through 6- and 12-months
NT-proBNP (12 months)
Change in NT-proBNP evaluated over time from baseline through 12 months
Time frame: Baseline through 12 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Change in KCCQ scores evaluated over time from baseline through 6 and 12 months
Time frame: Baseline through 6- and 12-months
6-minute Walk Test (6MWT)
Change in 6MWT evaluated over time from baseline through 6 and 12 months
Time frame: Baseline through 6- and 12-months
Worsening Heart Failure (Time to)
Time to first heart failure hospitalization or worsening heart failure event through 6 and 12 months
Time frame: Baseline through 6- and 12-months
Worsening Heart Failure (Incidence)
Incidence of heart failure hospitalization and worsening heart failure events through 6 and 12 months
Time frame: Baseline through 6- and 12-months
Composite Endpoint
Hierarchical composite endpoint of cardiovascular death, heart failure events, and changes from baseline to 12 months in KCCQ OSS
Time frame: Baseline through 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.