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Procedure
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF (Rebalance-HF Trial)
N/A
Waitlist Available
Research Sponsored by Axon Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Summary
This trial is testing if destroying a specific nerve using a catheter can help patients with a certain type of heart failure. The goal is to see if this treatment can improve their heart function and symptoms.
Eligible Conditions
- Diastolic Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endpoint
Primary Safety Outcome
Secondary study objectives
Endpoints
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Axon Treatment ArmActive Control1 Intervention
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.
Group II: Sham Control ArmPlacebo Group1 Intervention
Following administration of anesthesia subjects will have femoral vein access only. Procedure choreography to mimic procedure steps and length.
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Who is running the clinical trial?
Axon Therapies, Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Heart Failure
30 Patients Enrolled for Heart Failure