Early Feasibility Evaluation of Transmural Systems Transcaval Closure Device (TCD) for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (TAVR)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
研究概览
简要总结
Background:
Transcatheter aortic valve replacement (TAVR) is a non-surgical alternative to standard surgical aortic valve replacement. Not all patients are eligible for TAVR using standard access through the artery in the groin, because the artery is too small or too diseased. In this study, TAVR is performed using a new technique called transcaval access. The catheter is placed in the artery deep in the body by crossing through the wall of a deep vein. The connection between that vein and the aorta is closed with a new metallic device they are testing. This is called a transcaval closure device (TCD).
Objective:
To test the safety and early feasibility of closure of transcaval aortic access sites using the TCD after TAVR.
Eligibility:
Adults ages 21 and older undergoing TAVR for whom the procedure cannot be performed safely by the standard artery approach
Design:
Participants will be assessed by heart experts including cardiologists and surgeons.
Participants will have TAVR by the transcaval approach. A small catheter will be passed between the largest vein in the body and the nearby largest artery (aorta), inside the abdomen. Through this catheter, the TAVR will be implanted in the usual way.
After, doctors will implant the TCD by catheter to close the hole made in the aorta.
Participants will be X-rayed. A dye will be injected to view the TCD device.
Participants will get standard TAVR care afterwards. They will have physical exams, blood tests, and scans.
Participants will have a follow-up scan within 1 month and after 12 months.
Participants will have follow-up visits and phone calls 6 and 12 months after the procedure.
详细描述
Transcaval access to the abdominal aorta from the neighboring inferior vena cava (IVC) enables transcatheter aortic valve replacement (TAVR) in patients not eligible for femoral artery access. Currently the procedure is performed using devices, off-label, designed and marketed to close holes inside the heart and great vessels, manufactured by Abbott St Jude (Amplatzer Duct Occluder and Amplatzer Muscular VSD Occluder). Because these Amplatzer occluders are not designed to close transcaval access sites, they may not completely prevent bleeding.
This is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access. The device, the Transcaval closure device (TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
时间窗: 1 minute following procedure discharge (Exit from the catheterization laboratory)
Number of participants with technical success of delivery of the transcaval closure device (TCD) All of the following must be present for technical success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
次要结局
- Number of Participants With Closure Success of the Transcaval Closure Device (TCD)(1 minute following procedure discharge (Exit from the catheterization laboratory))
- Number of Participants That Experienced Procedural Success(30 Days)
- Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site(During procedure, procedure may last from 2 to 4 hours)
- Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography(Day 30, 12 months)
- Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)(30 days and 12 Months)
- Number of Participants Who Experienced Major Adverse Cardiovascular Events(Day 30)
- Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)(30 Days and 12 Months)
- All-Cause Mortality(30 Days)
- Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3(30 Days)
- Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device(30 Days)
- Number of Participants Enrolled Greater Than 65 Years(Enrollment)
- Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device(30 Days)
- Participant Cumulative Computed Tomography Analysis of Device(Day 30)
- Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications(30 days)
- Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications(30 Days)
- Number of Participants That Are Free From Infection Related to the Transcaval Closure Device(Day 30, 12 Months)
- Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure(During procedure, procedure may last from 2 to 4 hours)
- Number of Participants Final Acute Aorto-caval Fistula Score(30 Days)