Actively Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
Led by Axon Therapies, Inc. · Updated on 2026-03-13
150
Participants Needed
20
Research Sites
451 weeks
Total Duration
On this page
Sponsors
A
Axon Therapies, Inc.
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic heart failure with symptoms requiring diuretics treatment for more than 30 days
- New York Heart Association (NYHA) class II with history of higher class, class III, or ambulatory class IV symptoms at screening
- At least one of the following: one or more heart failure hospital admissions in past 12 months, elevated NT-proBNP or BNP levels within past 6 months, or right heart catheterization showing elevated pulmonary capillary wedge pressure
- Stable guideline-directed medical therapy for heart failure for at least 1 month prior to screening and expected to remain stable for 6 months
- Left ventricular ejection fraction of 50% or greater within past 6 months
- Age 40 years or older
- Ability and willingness to provide informed consent and follow study procedures
You will not qualify if you...
- Heart attack or cardiac intervention within 3 months prior to screening, or current need for coronary revascularization
- Cardiac resynchronization therapy started within 3 months prior to screening
- Advanced heart failure including non-ambulatory NYHA class IV, inotropic infusion within 6 months, on transplant list, or history of mechanical circulatory support
- Poor left heart compliance or right heart dysfunction based on echocardiogram
- Body mass index over 45 kg/m2
- Six-minute walk test distance less than 100 meters or over 450 meters
- Hospital admission for heart failure within 30 days before procedure
- History or presence of orthostatic hypotension or related syndromes
- Systolic blood pressure below 100 mmHg or above 170 mmHg despite treatment
- Resting heart rate over 100 beats per minute or ventricular tachycardia
- Catheter ablation for atrial fibrillation within 6 months prior or planned in next 12 months
- Left ventricular ejection fraction below 40% within past 3 years unless transient
- Significant valve disease as defined by cardiologist
- Known cardiomyopathies such as hypertrophic or restrictive types
- Significant liver cirrhosis
- Prior weight loss surgery
- Dialysis dependent or severely reduced kidney function
- Low arterial oxygen saturation below 90% on room air
- Chronic pulmonary disease requiring continuous oxygen or hospitalization in past year
- Participation in conflicting investigational studies within 30 days prior
- Life expectancy less than 12 months for non-cardiovascular reasons
- Conditions or history that may affect study results or increase risk as judged by investigators
- Pregnancy or lactation
- Abnormal right heart catheterization measurements
- Vascular anatomy or previous spine surgery that prevents safe procedure access
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Cardiology PC
Birmingham, Alabama, United States, 35211
Completed
2
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States, 85016
Active, Not Recruiting
3
Scripps Health
La Jolla, California, United States, 92037
Active, Not Recruiting
4
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
5
Bluhm Cardiovascular Institute of Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Prairie Education and Research Cooperative
Springfield, Illinois, United States, 62701
Active, Not Recruiting
8
Ascension St. Vincent - Cardiovascular Research Institute
Indianapolis, Indiana, United States, 46260
Completed
9
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
10
Michigan Medicine, University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
12
St. Louis Heart and Vascular
St Louis, Missouri, United States, 63136
Actively Recruiting
13
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
14
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Active, Not Recruiting
15
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
16
Rochester General Hospital
Rochester, New York, United States, 14621
Actively Recruiting
17
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
18
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
19
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
20
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
Active, Not Recruiting
Research Team
J
Judit Adorjan
CONTACT
J
Jennifer Moore, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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