Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
Sponsor: Axon Therapies, Inc. • ClinicalTrials.gov ID: NCT04592445
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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.
Interventions
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Greater Splanchnic Nerve Ablation
(Device)
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.
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Sham Control
(Device)
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.
Eligibility criteria
Conditions
Locations
- Cardiology PC — Birmingham, Alabama, United States
- Arizona Cardiovascular Research Center — Phoenix, Arizona, United States
- Scripps Health — La Jolla, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States
- Piedmont — Augusta, Georgia, United States
- Bluhm Cardiovascular Institute of Northwestern University — Chicago, Illinois, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Prairie Education and Research Cooperative — Springfield, Illinois, United States
- Ascension St. Vincent - Cardiovascular Research Institute — Indianapolis, Indiana, United States
- Cardiovascular Institute of the South — Houma, Louisiana, United States
- Michigan Medicine, University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- St. Louis Heart and Vascular — St Louis, Missouri, United States
- Weill Cornell Medicine — New York, New York, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Rochester General Hospital — Rochester, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- The Christ Hospital — Cincinnati, Ohio, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Baylor College of Medicine — Houston, Texas, United States
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
- Tbilisi Heart and Vascular Center — Tbilisi, Georgia
- Tbilisi Heart Center — Tbilisi, Georgia
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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