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Procedure

Axon Treatment Arm for Heart Failure (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

Awards & highlights

Rebalance-HF Trial Summary

This trial is testing a new treatment for heart failure that involves numbing a nerve to see if it improves symptoms.

Eligible Conditions

Diastolic Heart Failure

Rebalance-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endpoint

Primary Safety Outcome

Secondary outcome measures

Endpoints

Rebalance-HF 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are undergoing evaluation in this research endeavor?

"Axon Therapies, Inc. must recruit 80 suitable participants in order to execute the trial at its various locations, such as Virginia Commonwealth University Medical Center and Icahn School of Medicine at Mount Sinai."

Answered by AI

How widely is this research project administered across different sites?

"Virginia Commonwealth University Medical Center in Richmond, Virginia, Icahn School of Medicine at Mount Sinai in New york City and the Gazes Cardiac Research Institute located within the Medical University of South carolina in Charleston are three key patient-recruiting locations. Supplementally, there are 18 other sites participating as well."

Answered by AI

Is this study recruiting participants currently?

"Affirmative. According to clinicaltrials.gov, this experiment is actively recruiting participants from 18 different locations with the aim of finding 80 patients in total. It was initially posted on December 18th 2020 and was recently updated on December 14th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF

2020. "Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04592445.