Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF (Rebalance-HF)
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|ClinicalTrials.gov Identifier: NCT04592445|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : January 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Preserved Ejection Fraction||Device: Satera GSN Ablation Device: Sham Control||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Subjects randomized 1:1 (treatment to sham control); cross-over offered|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Subject and HF Cardiologist providing care are blinded. Interventionalist who performs the Index procedure is not|
|Official Title:||ENDOVASCULAR ABLATION OF THE RIGHT GREATER SPLANCHNIC NERVE IN Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF: Feasibility Study: Randomized Controlled Feasibility Trial- Rebalance HF Study|
|Actual Study Start Date :||December 18, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||March 2023|
Active Comparator: Axon Treatment Arm
Subjects will receive treatment with the Satera Ablation System following administration of anesthesia access to the R GSN and ablation of the GSN at 1-2 levels will occur.
Device: 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 Comparator: Sham Control Arm
Following administration of anesthesia subjects will have femoral vein access only. Procedure choreography to mimic procedure steps and length.
Device: 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).
- Primary Outcome Endpoint [ Time Frame: 1 Month ]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
- Primary Safety Outcome [ Time Frame: 1 month ]Evaluation of device or procedure-related serious adverse events at 1-month follow up based on Clinical Events Committee (CEC) assessment.
- Secondary Outcome Endpoints [ Time Frame: 1, 3, 6, and 12 months ]* Quality of Life: Change in KCCQ score evaluated over time from baseline and 1, 3, 6, and 12-months follow up.
- Secondary Outcome Endpoints [ Time Frame: 1, 3, 6, and 12 months ]*Change in 6MWT distance evaluated over time from baseline and 1, 3, 6, and 12 months follow up.
- Secondary Outcome Endpoints [ Time Frame: 1, 3, 6, and 12 months ]*Incidence of heart failure hospitalization through 12 months
- Secondary Outcome Endpoints [ Time Frame: 1 month ]*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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592445
|Contact: Sierra Yearsleyfirstname.lastname@example.org|