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.
Up to 150 people will take part in this clinical study. Phase I of the REBALANCE-HF Study The first part of the study took place between January 2021 and March 2023. During this phase, 116 patients participated. Researchers reviewed the results to learn whether the procedure appeared safe and whether it might help improve symptoms in people with heart failure with preserved ejection fraction (HFpEF). This early review showed encouraging results in some patients. It also helped researchers identify a group of patients who seemed more likely to benefit from the procedure. Phase II of the REBALANCE-HF Study: The current phase of the study focuses on patients who have similar characteristics to those who responded well in Phase I. The goal is to confirm whether this group of patients may benefit most from the treatment and whether the procedure should be studied further in a larger future trial. This study will take place at multiple hospitals and research centers. Participants who qualify for the study will be randomly assigned to one of two groups: * Treatment group: The procedure is performed using the Satera Ablation System to treat a nerve called the greater splanchnic nerve. * Control (sham) group: A simulated procedure is performed, but the treatment itself is not delivered. Participants will be assigned to a group by chance, similar to flipping a coin, although twice as many patients will receive the treatment as the sham procedure (2:1 ratio). The group assignment will happen during the procedure after anesthesia is given, and only after the doctor confirms that the patient's anatomy is suitable for the procedure. Blinding: To make sure the results are fair and unbiased: * Participants and their heart failure doctors will not know whether the patient received the treatment or the sham procedure. * The doctor performing the procedure and certain study staff will know which procedure is performed so they can carry out the procedure safely. * The study safety team will also know this information to help monitor patient safety. Sham Procedure: A sham procedure is used to help researchers understand whether any improvements are due to the treatment itself or to the placebo effect. During the sham procedure: A small needle puncture is made in the groin or neck, similar to what is done for many heart procedures. Doctors check the veins to confirm whether the procedure could have been performed. However, the treatment catheter is not used and the nerve is not treated. The sham procedure takes about 45 minutes, which is about the same amount of time as the treatment procedure. Number of Participants: 90 patients were assigned to treatment or sham during Phase I. In Phase II, up to 60 additional patients will be enrolled. About 40 patients will receive the treatment, and about 20 will receive the sham procedure.
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.
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.
Primary Safety Endpoint: Device or procedure related serious adverse events
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
Primary Efficacy Endpoint: KCCQ (6 months)
Assessment of change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 6-month follow up visit
Time frame: Baseline through 6-months
Primary Efficacy Endpoint: 6MWT (6 months)
Assessment of change in Six Minute Walk Test (6MWT) from baseline to the 6-month follow up visit
Time frame: Baseline through 6 months
Pulmonary Capillary Wedge Pressure (PCWP)
Change in pulmonary capillary wedge pressure (PCWP) at resting, legs up, 20 Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit
Time frame: Baseline through 1-month
Stress blood volume
Change in estimated stress blood volume at resting, legs up, 20Watts, and Peak Exercise Stage from Baseline to the 1-month follow up visit.
Time frame: Baseline through 1-month
NT-proBNP
Change in NT-proBNP levels from Baseline through the 24-month visit
Time frame: Baseline through 24-months
KCCQ (24-months)
Change in KCCQ scores from baseline through the 24-month visit
Time frame: Baseline through 24-months
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Cardiology PC
Birmingham, Alabama, United States
COMPLETEDArizona Cardiovascular Research Center
Phoenix, Arizona, United States
COMPLETEDScripps Health
La Jolla, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGZuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
RECRUITINGPiedmont
Augusta, Georgia, United States
NOT_YET_RECRUITINGBluhm Cardiovascular Institute of Northwestern University
Chicago, Illinois, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGPrairie Education and Research Cooperative
Springfield, Illinois, United States
COMPLETEDAscension St. Vincent - Cardiovascular Research Institute
Indianapolis, Indiana, United States
COMPLETED...and 16 more locations
6MWT (24-months)
Change in 6MWT from Baseline through the 24-month visit
Time frame: Baseline through 24-months
Time to first heart failure event
Time to first heart failure event (hospitalizations and worsening heart failure events) through the 24-month visit
Time frame: Treatment through 24-months
Incidence of heart failure events
Incidence of heart failure events (hospitalizations and worsening heart failure events) through the 24-month visit
Time frame: Treatment through 24-months
Hierarchical composite endpoint (12-months)
Composite endpoint of cardiovascular death, heart failure events, and changes in KCCQ from Baseline to the 12-month visit
Time frame: Baseline through 12-months
Incidence of serious device related cardiac or vascular events
Assessment of the incidence of serious device related cardiac or vascular events through 12- and 24-months
Time frame: Treatment through 12- and 24-months
Device or procedure related pain
Assessment of device or procedure related pain lasting at least 30 days and requiring medical management
Time frame: Treatment through 24-months
Orthostatic hypotension
Incidence of new orthostatic hypotension up to 12- and 24-months
Time frame: Treatment through 12- and 24-months
Acute Kidney Injury (AKI)
Incidence of AKI requiring renal replacement therapy up to 12- and 24-months
Time frame: Baseline through 12-and 24-months
Glomerular Filtration Rate (GFR)
Incidence of worsening GFR (defined as \>50% for at least 30 days in duration) up to 12- and 24-months
Time frame: Baseline through 12- and 24-months
Adverse Events
Incidence of all Adverse Events through 12- and 24-months
Time frame: Procedure through 12- and 24-months
Mortality
Incidence of all mortality for up to 6-, 12-, and 24-months summarized as all-cause mortality, CV mortality, or heart failure-related
Time frame: Procedure through 6-, 12- and 24-months