Back to resultsEndovascular GSN Ablation in Subjects With HFpEF
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring Heart Failure, Preserved Ejection Fraction
Eligibility 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
Sites / Locations
- Nemocnice Na Homolce
- Tbilisi Heart and Vascular Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ablation
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Change in average PCWP as compared to baseline
Change in average PCWP as compared to baseline
Secondary Efficacy Endpoint
Change in the quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) between baseline and follow-up
Secondary Efficacy Endpoint
Change in exercise tolerance as measured by the 6 minute walk test (6MWT) between baseline and follow-up
Full Information
NCT ID
NCT04287946
First Posted
February 19, 2020
Last Updated
February 16, 2022
Sponsor
Axon Therapies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04287946
Brief Title
Endovascular GSN Ablation in Subjects With HFpEF
Official Title
Endovascular Ablation of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction - First In-human Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axon Therapies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
Heart Failure, Preserved Ejection Fraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ablation
Intervention Description
Ablation of a single-side of the greater splanchnic nerve
Primary Outcome Measure Information:
Title
Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE)
Description
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
Title
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Description
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality
Description
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality
Time Frame
6 month
Title
Change in average PCWP as compared to baseline
Description
Change in average PCWP as compared to baseline
Time Frame
1 month
Title
Secondary Efficacy Endpoint
Description
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
Title
Secondary Efficacy Endpoint
Description
Change in exercise tolerance as measured by the 6 minute walk test (6MWT) between baseline and follow-up
Time Frame
1, 3, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Levin, MD
Organizational Affiliation
Coridea, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Nemocnice Na Homolce
City
Praha
Country
Czechia
Facility Name
Tbilisi Heart and Vascular Clinic
City
Tbilisi
Country
Georgia
12. IPD Sharing Statement
Citations:
PubMed Identifier
36175060
Citation
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.
Results Reference
derived
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Endovascular GSN Ablation in Subjects With HFpEF
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