Endovascular Ablation of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction - First In-human Feasibility Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- Axon Therapies, Inc.
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Mean change of PCWP with exercise after index procedure ablation as compared to baseline
- Status
- Enrolling by Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Time Frame: 1 month
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE)
Time Frame: 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
Secondary Outcomes
- Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality(6 month)
- Secondary Efficacy Endpoint(1, 3, 6 months)
- Change in average PCWP as compared to baseline(1 month)