The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).
This clinical investigation is a prospective, multi-center randomized, sham control, double blinded feasibility clinical study. Both the subject and the noninvasive cardiologist that is caring for the subject will be blinded to the assigned cohort (treatment or sham). The interventional cardiologist who performs the index procedure will not be blinded. Subjects who meet the eligibility criteria and are enrolled will be randomized 1:1 to either ablation of the right GSN using the Axon System (treatment cohort) or sham (control cohort) at the time of the procedure. This study will enroll up to 100 subjects at an anticipated 20 US sites. Subject follow up is at 1, 3, 6, and 12 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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 .
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).
Cardiology PC
Birmingham, Alabama, United States
RECRUITINGPrimary Outcome Endpoint
Change in mean PCWP at 1 month follow up evaluated as a repeated measure at rest, legs up and exercise (20W) as compared to the baseline PCWP evaluation. This reduction will be assessed in all subjects (both treated and control) to explore mechanism of action
Time frame: 1 Month
Primary Safety Outcome
Evaluation of device or procedure-related serious adverse events at 1-month follow up based on Clinical Events Committee (CEC) assessment.
Time frame: 1 month
Secondary Outcome Endpoints
\* Quality of Life: Change in KCCQ score evaluated over time from baseline and 1, 3, 6, and 12-months follow up.
Time frame: 1, 3, 6, and 12 months
Secondary Outcome Endpoints
\*Change in 6MWT distance evaluated over time from baseline and 1, 3, 6, and 12 months follow up.
Time frame: 1, 3, 6, and 12 months
Secondary Outcome Endpoints
\*Incidence of heart failure hospitalization through 12 months
Time frame: 1, 3, 6, and 12 months
Secondary Outcome Endpoints
\*Reduction in PCWP at 1 month follow up at rest, legs up, exercise at 20W and peak exercise as compared to the baseline PCWP evaluation.
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
RECRUITINGScripps Health
La Jolla, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGBluhm Cardiovascular Institute of Northwestern University
Chicago, Illinois, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
NOT_YET_RECRUITINGPrairie Education and Research Cooperative
Springfield, Illinois, United States
RECRUITINGCardiovascular Institute of the South
Houma, Louisiana, United States
RECRUITINGMichigan Medicine, University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITING...and 7 more locations