Invasive nerve ablation procedure for relief of heart failure symptoms.
Rajeev Mohan, MD
The Axiom System is an investigational device designed to deliver radiofrequency ablation to the greater splanchnic nerve (GSN) to normalize key heart and lung pressures and reduce symptoms of heart failure. Study requires five visits over 24 months.
Be 40 years of age or older
Have chronic heart failure diagnosis
Be currently taking treatment with oral diuretic for 30 days or more
Have an LVEF = 50 % determined by echocardiogram within the past 6 months.
Patients must not:
Have a BMI > 45 kg/m2
Have a history of clinically significant liver cirrhosis
Be dialysis dependent
Have chronic pulmonary disease requiring continuous home oxygen.
Be unable to walk less than 100 meters OR a distance greater than 450 meters in six minutes.
Eligible participants will be randomized to either ablation using the Axon System (treatment cohort) or a sham procedure (control cohort). Participants will have post-procedure follow-up visits at 7 days, and 1, 3, 6 and 12-months.