Transcaval Access for Transcatheter Aortic Valve Replacement in Patients With No Good Options for Aortic Access
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 15
- 主要终点
- The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
研究概览
简要总结
Background:
- Some people who need a transcatheter aortic valve replacement (TAVR) have leg arteries that are too small and are too sick for standard techniques. But they may benefit from a new technique called transcaval TAVR. For this technique, doctors make a hole between the largest vein (vena cava) and largest artery (aorta) in the body, inside the abdomen. Then they replace the valve through a tube they put in the groin vein. Then they close the hole between the vein and the artery using a device designed to close holes in the heart. This study tests the device for this new, off-label use.
Objective:
- To further study the safety and effectiveness of transcaval TAVR.
Eligibility:
- Adults age 21 and older who would benefit from TAVR but for whom standard techniques are not suitable.
Design:
- Participants will be selected by a team of heart specialists and others.
- Participants will have a computed tomography (CT) scan with or without contrast dye.
- Participants will have blood tests.
- Participants will have transcaval TAVR.
- Participants will receive the same standard care as for all patients with TAVR.
- Participants will also have another CT scan, or an MRI or ultrasound, before they leave the hospital, and again after about 30 days and after about 12 months.
- Participants will be contacted 1 and 6 months afterwards and will have another visit 1 year later. They will have a CT, MRI, or ultrasound. They will have blood tests and a physical exam.
详细描述
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) has enabled transcatheter aortic valve replacement (TAVR) in a small number of patients who have no good options for standard percutaneous femoral access or for standard surgical access to the cardiac apex or to the ascending aorta. In this prospective registry we will collect data from multiple medical centers as they offer transcaval TAVR to patients with extreme or prohibitive risk of conventional TAVR.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Adults age greater than or equal to 21 years
- •Severe symptomatic de novo aortic valve stenosis or bioprosthetic aortic valve failure for which transcatheter aortic valve replacement (TAVR) is felt beneficial according to the consensus of the institutional multidisciplinary heart team
- •Extreme risk or inoperability for TAVR via conventional femoral artery, trans-apical, or trans-aortic access in the determination of the multidisciplinary heart team. This determination includes an in-person consultation by at least one cardiac surgeon member of the heart team.
- •Anatomic eligibility for caval-aortic TAVR, graded as favorable or feasible based on NHLBI core lab assessment of the baseline CT examination.
排除标准
- •Unable or unwilling to consent to participate
- •Anatomic eligibility for caval-aortic TAVR graded as unfavorable based on NHLBI core lab assessment of the baseline CT examination
- •Unlikely to benefit from caval-aortic TAVR
- •Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements.
研究组 & 干预措施
A
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
干预措施: CA-TAVR (Procedure)
A
Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
干预措施: Amplatzer Duct Occluder (Device)
结局指标
主要结局
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
时间窗: 1 year
The primary endpoint is device success, which is defined as successful transcaval access and deployment of a closure device without death or emergency open surgery related to caval-aortic access
次要结局
未报告次要终点