80
Participants
Start Date
December 18, 2020
Primary Completion Date
April 30, 2022
Study Completion Date
March 31, 2023
Satera GSN Ablation
The Axon procedure consists of a small needle puncture made in the groin to pass standard sheaths, wires, and access devices into the femoral vein, using standard access methods. The right GSN will be ablated transvenously from the right intercostal veins where it crosses at the 10th and 11th thoracic vertebrae from the intercostal vein intersection with the azygos vein. Placement of the access devices and Axon catheter is confirmed using standard fluoroscopic imaging. Once positioning is confirmed, GSN ablation can commence accordingly .
Sham Control
The sham procedure consists of a small needle puncture made in the groin to pass a standard femoral introducer sheath approximately 10 cm into the femoral vein, using standard access methods. The Axon Catheter and associated access accessories will not be inserted into the patient. The sham procedure duration will be similar to the treatment time for subject receiving the Axon therapy (\~30 minutes).
RECRUITING
Weill Cornell Medicine, New York
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Center for Advanced Cardiac Care, Columbia University Medical Center, New York
NOT_YET_RECRUITING
Virginia Commonwealth University Medical Center, Richmond
RECRUITING
Duke University Medical Center, Durham
RECRUITING
Medical University of South Carolina, Gazes Cardiac Research Institute, Charleston
RECRUITING
Cardiology PC, Birmingham
RECRUITING
Ohio State University Wexner Medical Center, Columbus
RECRUITING
Michigan Medicine, University of Michigan, Ann Arbor
RECRUITING
Mayo Clinic, Rochester
RECRUITING
Bluhm Cardiovascular Institute of Northwestern University, Chicago
NOT_YET_RECRUITING
University of Chicago Medical Center, Chicago
RECRUITING
Prairie Education and Research Cooperative, Springfield
RECRUITING
Cardiovascular Institute of the South, Houma
RECRUITING
Arizona Cardiovascular Research Center, Phoenix
RECRUITING
Scripps Health, La Jolla
RECRUITING
University of California, San Francisco, San Francisco
Lead Sponsor
Axon Therapies, Inc.
INDUSTRY