Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects randomized 1:1 (treatment to sham control); no cross overMasking: Double (Participant, Outcomes Assessor)Masking Description: Subject and HF Cardiologist providing care are blinded. Interventionalist who performs the Index procedure in notPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Both males and females
Description
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...
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
Tracking Information
- NCT #
- NCT04592445
- Collaborators
- Not Provided
- Investigators
- Not Provided
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