Endovascular Ablation of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction - First In-human Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Mean change of PCWP with exercise after index procedure ablation as compared to baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
时间窗: 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)
时间窗: 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
次要结局
- 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(1 month)
- Secondary Efficacy Endpoint(1, 3, 6 months)