Endovascular GSN Ablation in Subjects With HFpEF

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure With Preserved Ejection Fraction

Intervention / Treatment
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* Device: Ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation<br> | Device: Ablation<br>* Ablation of a single-side of the greater splanchnic nerve<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Preserved Ejection Fraction