Streamlined One-wire Logistics Optimize Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Transcatheter heart valve device migration/embolization or inability to complete BAV procedure.
研究概览
简要总结
The goal of this study is to determine the safety and performance of a new guidewire and pacing system called the Fusion System in treating patients undergoing transcatheter aortic valve replacement (TAVR) or similar procedures. The main questions it aims to answer are:
Is the Fusion System safe? Is the Fusion System's clinical performance acceptable?
Participants will asked to sign a study consent and report any adverse events experienced until they are discharged from hospital (or a maximum of 2 days following their procedure).
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for a THV or BAV procedure in accordance with standard institutional protocols requiring temporary pacing.
- •Willing and able to comply with the follow-up evaluations
- •Been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
排除标准
- •Undergoing an emergent procedure
- •An ST elevation myocardial infarction (STEMI) within 7 days of procedure
- •Had cardiac arrest within 7 days of procedure requiring CPR or defibrillation
- •An indication to require mechanical cardiac support (MCS) post-procedure
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical circulatory support within 30 days prior to index procedure
- •Active endocarditis within 30 days prior to index procedure
- •Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- •Severe aortic annular or sub annular calcium per operator evaluation.
- •Bicuspid aortic valve stenosis WITH severe raphe calcium per operator evaluation.
- •Had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 90 days of index procedure
- •Severe peripheral vascular disease that would preclude safe placement of an introducer sheath
- •A planned alternative (i.e., non-femoral) access site
- •A comorbidity that would preclude index procedure or use of the Solo Pace Fusion System
- •A known, untreated neurological, psychological, psychiatric or other disorder that would interfere with trial endpoints or with cooperation with the requirements of the trial
- •Participating in another investigational drug or device study
- •Pregnant, lactating, or plan to become pregnant during the study (women of child-bearing potential must have a pregnancy test).
结局指标
主要结局
Transcatheter heart valve device migration/embolization or inability to complete BAV procedure.
时间窗: Intraprocedure
Incidence of failure of the Solo Pace Fusion System to provide adequate pacing leading to transcatheter heart valve device migration/embolization or the inability to complete the BAV procedure
Successful deployment of THV or BAV system over the Fusion Guidewire
时间窗: Intraprocedure
The Primary Performance Endpoint for the study consists of the following criteria (note: both criteria must be met): * Successful delivery to the intended position and successful deployment of a commercially available THV or BAV delivery system over the Fusion Guidewire * Successful pacing during THV or BAV deployment in unipolar configuration using the Fusion System
次要结局
未报告次要终点