Endovascular GSN Ablation in Subjects With HFpEF

NCT04287946 | Enrolling By Invitation FDA Device

• 1 other identifier: 08938
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Heart Failure; Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  1 month

• Secondary Efficacy Endpoint

  1, 3, 6 months

• Secondary Efficacy Endpoint

  1, 3, 6 months

Study Arms (1)

Ablation

EXPERIMENTAL

Device: Ablation

Interventions

Ablation DEVICE

Ablation of a single-side of the greater splanchnic nerve

Ablation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axon Therapies, Inc.: lead

Study Sites (3)

Nemocnice Na Homolce

Prague, Czechia

Location

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

Location

Tbilisi Heart Center

Tbilisi, Georgia

Location

Related Publications (1)

• 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.

  PMID: 36175060 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Howard Levin, MD

  Coridea, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 27, 2020
• Study Start: February 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

CZ (1); GE (2)