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Endovascular Ablation for Heart Failure with Preserved Ejection Fraction (HFpEF)

This study is looking at a procedure called Greater Splanchnic Nerve Ablation using the Satera Ablation System for people with a type of heart failure called Heart Failure with Preserved Ejection Fraction (HFpEF). This procedure involves guiding thin tubes through a vein to treat a nerve called the right greater splanchnic nerve. The study aims to see if this treatment is safe and if it can improve symptoms. You might be able to join if you are 40 or older and have chronic heart failure with specific symptoms, including those requiring diuretics. Researchers will measure safety by looking at serious side effects within one month, and effectiveness by checking your quality of life (KCCQ) and walking ability (6MWT) over six months. The study is currently in its second phase, focusing on up to 150 participants who may benefit most from this treatment.

Study design
This study is an interventional trial with up to 150 participants. You will be randomly assigned to either receive the Greater Splanchnic Nerve Ablation procedure or a sham control procedure.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked for one month after the procedure. Your quality of life and walking ability will be followed for six months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04592445

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

Recruiting
NAAges 40+InterventionalTreatment
Axon Therapies, Inc.
~150 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Greater Splanchnic Nerve AblationSham Control

At a glance

Recruiting sites
13 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint: Device or procedure related serious adverse events
Measured over 1 Month
+2 more outcomes measured

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

20 sites across 14 states
New York4
Illinois3
California2
Alabama1
Arizona1
Indiana1
Louisiana1
Michigan1

Study leadership

  • Sanjiv S Shah, MD · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Judit Adorjan
[email protected]
16507221119
Email the study team

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What this trial measures

  • Primary Safety Endpoint: Device or procedure related serious adverse events1 Month

    Evaluation of device or procedure-related serious adverse events at 1-month follow-up based on Clinical Events Committee (CEC) assessment

  • Primary Efficacy Endpoint: KCCQ (6 months)Baseline through 6-months

    Assessment of change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6-month follow up visit

  • Primary Efficacy Endpoint: 6MWT (6 months)Baseline through 6 months

    Assessment of change in Six Minute Walk Test (6MWT) from baseline to the 6-month follow up visit