Status:
ENROLLING_BY_INVITATION
Endovascular GSN Ablation in Subjects With HFpEF
Lead Sponsor:
Axon Therapies, Inc.
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
40-85 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04287946
Start Date
February 1 2020
End Date
November 1 2024
Last Update
February 2 2024
Active Locations (3)
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1
Nemocnice Na Homolce
Prague, Czechia
2
Tbilisi Heart and Vascular Clinic
Tbilisi, Georgia
3
Tbilisi Heart Center
Tbilisi, Georgia