A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the SPIKE FLOW Endocardial Lead
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 131
- 试验地点
- 3
- 主要终点
- Safety: Freedom from Severe ADEs
研究概览
简要总结
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead.
Primary objectives are to assess:
- safety in terms of freedom from Serious ADEs;
- performance in terms of Mean Pacing Capture Threshold.
Secondary objectives are to assess:
- safety in terms of freedom from ADEs;
- performance in terms of Mean Pacing Impedance;
- performance in terms of Sensed R-wave Amplitude. The study is a prospective, non-randomized, single-arm, multi-center investigation in 131 adult subjects with Up to 4 investigational sites in Italy.
The study is expected to take approximately 1 year to enroll. Enrolled subjects will have visit timepoints at: Baseline, lead insertion, lead removal, discharge and 30d post lead removal.
详细描述
SPIKE FLOW temporary leads are intended for temporary intravenous cardiac pacing and recording of intravenous cardiac electrical signals. The products are designed to be used for a continuous period of not more than 7 days. The indications for temporary pacing typically are the following:
- Acute myocardial infarction;
- Asystole;
- Bradycardia;
- AV block;
- Ventricular tachyarrhythmias;
- Overdrive suppression of tachyarrhythmias;
- High frequency pacing during percutaneous procedures;
- Cardiac surgery requiring backup pacing, surveillance of cardiac activity. The leads may be introduced, connected, and put into operation only by experienced and trained medical staff in heart pacing and percutaneous access.
The physicians entitled to place a temporary pacemaker should be familiar with the insertion equipment (puncture needle and sheath), electro-catheters and connectors, and the external pulse generator available in their own hospital settings.
Endocardial SPIKE FLOW family leads are single-use sterile devices, class III according to MDR (EU) 2017/745, used for temporary cardiac pacing, for short-term therapy of diseases which require the stimulation of the heart by means of electrical energy supplied by external pulse generators.
The rationale of the study is to evaluate, through clinical investigation according to its expected using conditions, the effectiveness of SPIKE FLOW device's performance and to confirm the safety of the medical device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subject undergoing a surgical or an interventional procedure, requiring temporary cardiac pacing per investigator's medical judgment or subjects with bradycardia who are under evaluation to determine if the cause is transient or permanent;
- •Subject is at least 18 years of age;
- •Subject provides written informed consent to the study.
排除标准
- •Subject has a co-exist temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator;
- •Subject on cardiogenic shock;
- •Subject is currently in atrial fibrillation;
- •Subject is pregnant or breastfeeding;
- •Subject had a stroke within 6 months prior to enrollment;
- •Subject has renal insufficiency with creatinine >2 mg/dl;
- •Subject with known bleeding diathesis;
- •Subject with a history of deep vein thrombosis or pulmonary embolization within 6 months;
- •Subject with known tricuspid valve disease that may impede catheter advance to and withdrawn from right ventricle;
- •Subject with known intracardiac thrombus or vegetation on echocardiography;
- •Subject with significant neck abnormalities such that placement of a right and/or left internal jugular vein line would be difficult;
- •Subject has an active systemic infection or local infection at or around the insertion site;
- •Subject is involved in another clinical study that could influence the safety or outcome measures of this study.
研究组 & 干预措施
experimental single-arm
干预措施: Lead insertion (Procedure)
experimental single-arm
干预措施: lead removal (Procedure)
结局指标
主要结局
Safety: Freedom from Severe ADEs
时间窗: from insertion up to 30 days post-lead removal
Performance: Mean Pacing Capture Threshold (>2V)
时间窗: from insertion to Lead removal (Up to 7 days)
次要结局
- Safety: Freedom from ADEs(from insertion up to 30 days post-lead removal)
- Performance: Mean Pacing Impedance (Ohms)(from insertion to Lead removal (Up to 7 days))
- Performance: Sensed R-wave Amplitude(from insertion to Lead removal (Up to 7 days))