Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
Heart Failure, Preserved Ejection Fraction
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.
Interventions
DEVICEAblation
Ablation of a single-side of the greater splanchnic nerve
Sponsors
Axon Therapies, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE) | 1 month | 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 | 1 month | Mean change of PCWP with exercise after index procedure ablation as compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality | 6 month | Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality |
| Change in average PCWP as compared to baseline | 1 month | Change in average PCWP as compared to baseline |
| Secondary Efficacy Endpoint | 1, 3, 6 months | Change in the quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) between baseline and follow-up |
Countries
Czechia, Georgia
Outcome results
None listed