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

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 Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Device: Ablation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia
    • Nemocnice na Homolce
• Georgia
  • Tbilisi, Georgia
    • Tbilisi Heart and Vascular Clinic
  • Tbilisi, Georgia
    • Tbilisi Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation	Device: Ablation; Ablation of a single-side of the greater splanchnic nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
Mean change of PCWP with exercise after index procedure ablation as compared to baseline	Mean change of PCWP with exercise after index procedure ablation as compared to baseline	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality	Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality	6 month
Change in average PCWP as compared to baseline	Change in average PCWP as compared to baseline	1 month
Secondary Efficacy Endpoint	Change in the quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) between baseline and follow-up	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	1, 3, 6 months

Collaborators and Investigators

• Sponsor: Axon Therapies, Inc.
• Investigators: Study Chair: Howard Levin, MD, Coridea, Inc.

Publications and helpful links

General Publications

• Fudim M, Zirakashvili T, Shaburishvili N, Shaishmelashvili G, Sievert H, Sievert K, Reddy VY, Engelman ZJ, Burkhoff D, Shaburishvili T, Shah SJ. Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study. JACC Heart Fail. 2022 Oct;10(10):744-752. doi: 10.1016/j.jchf.2022.05.009. Epub 2022 Jul 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Preserved Ejection Fraction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 08938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes