Safety and Efficacy of the ViaOne Device for Pericardial Access - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Safety of ViaOne device
研究概览
简要总结
ViaOne device is a tool designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac. In this study ViaOne will be used to obtain pericardial access in patients in whom electrophysiological diagnostic (mapping) and/or therapeutic (ablation) of epicardial sites via percutaneous subxiphoid approach to the to the normal, non-distended pericardial space is indicated.
详细描述
The primary objective of the study is to provide evidence of safety of ViaOne in obtaining percutaneous subxiphoid approach to the pericardial space. The secondary objective is to provide initial estimate of efficacy of ViaOne in obtaining percutaneous subxiphoid approach to the pericardial space.
Screening procedures will include laboratory analyses of the complete blood count, serum chemistry, coagulation parameters, and urine or serum ß-HCG test.A physical examination and collection of vital signs will be conducted. Medical history data and information on concomitant medications will be collected.
Once eligibility is verified, subjects will be scheduled for a procedure during which percutaneous subxiphoid pericardial access will be obtained using the ViaOne and its associated procedure. Time period between the study device insertion through the subxiphoid incision and guidewire insertion into the pericardial sac, overall time in procedure, and any procedural complications and device deficiencies will be recorded.
Follow-up visit will be conducted as part of the planned protocol procedures at up 5 ± 1 days after the procedure or at the time of discharge, whichever comes first. The visit will include evaluation of any adverse events and complications. Length of hospital stay will be recorded, where the discharge precedes or coincides with the final follow-up visit of the study.
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
- •Electrophysiological diagnostic (mapping) and/or therapeutic (ablation) of epicardial sites via percutaneous subxiphoid approach to the to the normal, non-distended ericardial space is indicated.
- •Pre-treatment coagulation values within the following limits:
- •international normalized ratio 0.8 - 1.2
- •partial thromboplastin time 25 - 35''
- •Pre-treatment hematology and biochemistry values within the following limits:
- •hemoglobin ≥ 10 g/dL (g/100 mL)
- •platelets ≥ 150 x 10^9/L (x 10^3/mm^3)
- •white blood cells ≥ 3.0 x 10^9/L (x 10^3/mm^3)
- •absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (1.5 x 10^3/mm^3)
- •serum creatinine < 1.5 mg/dL
- •aspartate aminotransferase < 1.5 x ULN (upper limit of norm)
- •alanine aminotransferase < 1.5 x ULN
- •alkaline phosphatase < 1.5 x ULN
- •Signed informed consent.
排除标准
- •History of cardiac or pericardial surgery or prior pericardial ablation.
- •History of chronic pericarditis.
- •Known pericardial fibrosis and/or adhesions.
- •Any anomaly in the chest anatomy.
- •Myocardial infarction, past or present.
- •Bleeding disorders.
- •Hepatic enlargement.
- •BMI > 40
- •Participation in another interventional trial.
- •Pregnancy.
结局指标
主要结局
Safety of ViaOne device
时间窗: through study completion, an average of 5 days
Incidence of device-related adverse events through study completion, an average of 5 days
次要结局
- Initial Efficacy of ViaOne device(through study completion, an average of 5 days)