Endovascular GSN Ablation in Subjects With HFpEF

Axon Therapies

Status: Invitation-only

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Device: Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04287946

08938

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Chronic heart failure
• Transthoracic echocardiographic evidence of diastolic dysfunction
• Ongoing stable GDMT HF management and management of potential comorbidities
• LVEF ≥50% in the past 3 months

Key Exclusion Criteria:

• Cardiac resynchronization therapy initiated within the past 6 months
• Advanced heart failure
• Admission for HF within the past 30 days
• Presence of significant valve disease
• Mean right atrial pressure (RAP) >20mmHg during hemodynamic screening

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ablation

Experimental group

Treatment:

Device: Ablation