Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Patients With Vascular Complications
研究概览
简要总结
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.
详细描述
This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age 18 or older
- •Transfemoral transcatheter aortic valve replacement (TAVR)
- •Implantation of CoreValve replacement valve
- •Access using 14 French sheaths
- •English speaking
排除标准
- •Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
- •Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
- •Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
- •Arterial or Venous Issues: Patients with small femoral arteries or veins (<5 mm in diameter), patients with access sites located in vascular grafts.
- •Body Composition: Patients with BMI >35
- •Cardiac Vasculature: Patients with excess calcification of vessels as determined by echocardiography and/or CT angiography
- •Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
- •Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count <100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
- •Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
- •Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
- •Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
- •Pregnancy and Lactation: Pregnant or lactating women.
- •Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
- •Contraindications: Patients with contraindications for the use of Perclose device.
研究组 & 干预措施
Single Device
A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.
干预措施: Single Perclose Pro vascular closure device (Device)
Two device
Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.
干预措施: Dual Perclose vascular closure device (Device)
结局指标
主要结局
Number of Patients With Vascular Complications
时间窗: Day 5 post-procedure
Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization.
Number of Patients With Life-threatening bleeding
时间窗: Hour 24 post-procedure
Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure.
Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition
时间窗: Hour 24 post-procedure
Number of subjects in each group experiencing bleeding complications related to the TAVR procedure that do not meet the criteria for life-threatening bleeding but still result in significant clinical concern within 24 hours of the index procedure.
Time to Hemostasis
时间窗: 1 hour post procedure
For each subject, time elapsed from initial deployment of the initial one or two Perclose devices (depending on assigned group) to complete hemostasis of the femoral access site. Measured in seconds.
次要结局
- Additional Closure Device Use(Hour 24 post-procedure)
- In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions(Day 5 post-procedure)
- Number of Patients With Limb Ischemia Related to TAVR During Index Admission(Day 5 post-procedure)
- Limb Ischemia Related to TAVR(Day 30 post-procedure)