Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure)
研究概览
简要总结
This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support.
详细描述
The study will enroll up to 31 subjects at one investigational site with at least 3 implanters.
The subjects enrolled will be followed 7 days after the Sync-AV II Temporary Cardiac Pacing Catheter is removed. A safety call or clinic visit at 7 days post discharge will be performed.
Only subjects who meet the inclusion/exclusion criteria and provide informed consent will be eligible to receive the treatment and participate in the study. potential subjects who have a surgical or interventional procedure that will require temporary cardiac pacing support for at least 24 hours per investigator's medical judgement.
The elective surgical or interventional procedure is to be performed per institutional standard of care. Other concomitant therapy (medication and non-medication therapies) may be used during the study for the treatment or prevention of disease or to maintain good health.
Study Procedure standard of care technique to access the right jugular vein. Thru an introducer the Sync-AV II Temporary Cardiac Pacing Catheter is inserted Confirm and document the leads location as a baseline reference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 is undergoing a surgical or an interventional procedure requiring temporary cardiac pacing to support for at least 24 hours per investigator's medical judgement.
- •Subject is at least 18 years of age.
- •Subject or legal representative 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.
结局指标
主要结局
With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure)
时间窗: 24 hours post implant
Number of participants with a mean ventricular pacing threshold of less than 2.1 volts, measured at 24 hours post index procedure.
Procedure related complications
时间窗: through study completion, an average of 7 days
Incidence of serious procedural related complications The procedure-related serious complication is defined as: * Device-related endocarditis * Clinically significant cardiac perforation * New pericardial effusions requiring intervention * Sustained ventricular or atrial arrhythmia * Cardiac tamponade * Bleeding requiring transfusion
次要结局
未报告次要终点