NCT04287946

Endovascular GSN Ablation in Subjects With HFpEF

Endovascular Ablation of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction - First In-human Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Axon Therapies, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and potential benefits of single-side block of a nerve that connects to the intestines, liver and spleen called the "greater splanchnic nerve" for the treatments of patients with symptomatic heart failure who have normal pumping of the heart. The study will be performed in patients whose heart failure is not responding well to standard treatments and remain symptomatic.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DEVICE	Ablation	Ablation of a single-side of the greater splanchnic nerve

Timeline

• Start date: 2020-02-01
• Primary completion: 2024-06-01
• Completion: 2024-11-01
• First posted: 2020-02-27
• Last updated: 2024-02-02

Locations

3 sites across 2 countries: Czechia, Georgia

Regulatory

• FDA-regulated device study