Endovascular GSN Ablation in Subjects With HFpEF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2024-11-30

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.

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Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ablation

Group Type EXPERIMENTAL

Ablation

Intervention Type DEVICE

Ablation of a single-side of the greater splanchnic nerve

Interventions

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Ablation

Ablation of a single-side of the greater splanchnic nerve

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No