Endovascular GSN Ablation in Subjects With HFpEF

Axon Therapies, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

AblationDEVICE

Ablation of a single-side of the greater splanchnic nerve

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (3)

Nemocnice Na Homolce

Prague, Czechia

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Tbilisi Heart Center

Tbilisi, Georgia

Outcomes

Primary Outcomes

Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE)

Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE) through 1-month follow up based on Independent Physician Adjudicator (IPA) assessment: Cardiovascular death; Embolic stroke; Device or procedure-related adverse cardiac events

Time frame: 1 month

Mean change of PCWP with exercise after index procedure ablation as compared to baseline

Time frame: 1 month

Secondary Outcomes

Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality

Time frame: 6 month

Change in average PCWP as compared to baseline

Time frame: 1 month

Secondary Efficacy Endpoint

Change in the quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) between baseline and follow-up

Time frame: 1, 3, 6 months

Secondary Efficacy Endpoint

Change in exercise tolerance as measured by the 6 minute walk test (6MWT) between baseline and follow-up

Time frame: 1, 3, 6 months

Data from ClinicalTrials.gov

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