Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAxon Therapies, Inc.
About this trial
The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF). The goal is to learn whether this procedure, performed using the Satera Ablation System, may help improve symptoms and to better understand which patients may benefit most from this treatment in the future.
Eligibility criteria
Qualifiers
Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for >30 days, AND
NYHA class II with a history of >NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or signs of HF (any rales post cough, chest x-ray demonstrating pulmonary congestion), AND
Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF/AHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations), with no significant changes [≥100% increase or ≥50% decrease] for a minimum of 1 month (30 days) prior to screening, that is expected to be maintained without change for at least 6 months. 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.
LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.
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 screening.
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
- Greater Splanchnic Nerve Ablation
- Sham Control
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Axon Therapies, Inc.
Lead sponsor
NAMSA
Collaborator
Cardiovascular Research Foundation, New York
Collaborator
Northwestern University
Collaborator
Source ClinicalTrials.gov