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

NCT04592445 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-13

No results posted yet for this study

Summary

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

  • Heart Failure With Preserved Ejection Fraction (HFpEF

Interventions

DEVICE

Greater Splanchnic Nerve Ablation

The greater splanchnic nerve (GSN) ablation procedure begins with a small needle puncture in the groin or neck to access a vein, using methods that are commonly used for heart procedures. Doctors then guide thin tubes and wires through the vein to reach a nerve called the right greater splanchnic nerve. X-ray imaging is used to help the doctor see where the catheter is and guide it to the correct location. Once the catheter is in the right place, the doctor uses the device to treat the nerve using controlled heat.

DEVICE

Sham Control

During the sham procedure, a small needle puncture will be made in the groin or neck to access a vein using standard medical techniques. A short tube will be placed into the vein, similar to what is done for many heart procedures. The Satera catheter and treatment devices will not be inserted, and the nerve will not be treated. The procedure will take about the same amount of time as the treatment procedure.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Cardiovascular Research Foundation, New York

    collaborator OTHER

  • Northwestern University Feinberg School of Medicine

    collaborator OTHER

  • Axon Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjiv S Shah, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2028-01-10
Completion
2029-08-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592445 on ClinicalTrials.gov