Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF — Rebalance-HF  

Heart Failure With Preserved Ejection Fraction Clinical Trial

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

Status Recruiting

Clinical Trial Summary

The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).

Clinical Trial 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 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 ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

• NCT number: NCT04592445
• Study type: Interventional
• Source: Axon Therapies, Inc.
• Contact: Sierra Yearsley
• Phone: 16508670927
• Email: s.yearsley@axontherapies.com
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2020
• Completion date: March 2023