Endovascular GSN Ablation in Subjects With HFpEF

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04287946
• Other study ID #: 08938
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Axon Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

Device:
• Ablation
Ablation of a single-side of the greater splanchnic nerve

Locations

Country	Name	City	State
Czechia	Nemocnice Na Homolce	Praha
Georgia	Tbilisi Heart and Vascular Clinic	Tbilisi
Georgia	Tbilisi Heart Center	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Axon Therapies, Inc.

Countries where clinical trial is conducted

Czechia,  Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Change in average PCWP as compared to baseline	Change in average PCWP as compared to baseline	1 month
Secondary	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	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