Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Heart Failure With Preserved Ejection Fraction (HFpEF

In brief

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.

Key facts

Study ID

NCT04592445

Run by

Axon Therapies, Inc.

People needed

150

Starts

2020-12-18

Expected to finish

2029-08-10

Last updated by the study team

2026-03-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic heart failure, defined as:
• 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
• At least one of the following:
• i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility within past 12 months, OR ii. NT-proBNP >300 pg/ml in normal sinus rhythm (>450 pg/ml in atrial fibrillation or flutter) within the past 6 months; BNP >100 pg/ml in normal sinus rhythm (>300 pg/ml in atrial fibrillation or flutter) within the past 6 months, OR iii. Right heart catheterization (RHC) with PCWP ≥ with PCWP ≥18 mmHg at rest or 25 mmHg during exercise at the time of the screening RHC.
• 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.
• Age ≥40 years.
• Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.

You may not qualify if…

• 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.
• Advanced heart failure defined as one or more of the following:
• ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
• Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
• Subject is on the cardiac transplant waiting list.
• Presence of or prior history of mechanical circulatory support for HF.
• Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E/A) ratio >2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the transmitral A velocity is not measurable or absent.
• Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) <12 mm or right ventricular (RV) fractional area change (FAC) <25% assessed by the screening echocardiogram.
• Body mass index (BMI) >45 kg/m2.
• 6-minute walk test distance <100 meters OR >450 meters.
• Admission for HF within the 30 days prior to planned index procedure.
• Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of >20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.
• Orthostatic pulse pressure change from supine to standing decrease of >10mmHg in the absence of a HR increase >15bpm
• Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.
• Systolic BP <100 mmHg or >170 mmHg despite appropriate medical management.
• Baseline screening ECG resting HR >100 beats per minute or ventricular tachycardia.
• Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.
• Left ventricular EF <40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.
• Presence of significant valve disease defined by the site cardiologist as:
• Greater than mild mitral valve stenosis.
• Greater than moderate mitral valve regurgitation.
• Greater than moderate-to-severe tricuspid valve regurgitation.
• Greater than moderate aortic valve stenosis or regurgitation.
• Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Rochester General Hospital — Rochester, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Bluhm Cardiovascular Institute of Northwestern University — Chicago, Illinois, United States (enrolling)
• Cardiovascular Institute of the South — Houma, Louisiana, United States (enrolling)
• Michigan Medicine, University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• St. Louis Heart and Vascular — St Louis, Missouri, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
• Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
• Scripps Health — La Jolla, California, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• Ascension St. Vincent - Cardiovascular Research Institute — Indianapolis, Indiana, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cardiology PC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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