The Holding Area LINQ Trial is a Prospective, Non-randomized, Single Center Post-market Clinical Trial Designed to Occur in the Holding Area of a Hospital Operating Room or Cardiac Catheterization/Electrophysiology Laboratory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.
研究概览
简要总结
The Holding Area LINQ Trial is a clinical trial designed to compare the benefits in conducting impant procedures in the holding area of a hospital operating room vs cardiac catheterization/electrophysiology laboratory.
详细描述
The Holding Area LINQ Trial is a prospective, non-randomized, single center post-market clinical trial designed to occur in the holding area of a hospital operating room or cardiac catheterization/electrophysiology laboratory. The primary objective is to characterize the rate of procedure-related complications within 90 days of the implant procedure which require resolution by surgical intervention. Twenty (20) patients with established clinical indications for the LINQ ICM (Reveal LINQ Insertable Cardiac Monitor) will be implanted using standard of care techniques and procedures. Implants will be required to take place in a hospital holding area rather than the traditional facility locations such as the hospital operating room, cardiac catheterization lab, or electrophysiology lab. A physical description of the holding area is a small patient examination room separated from other patient exam bay by walls and a door. There is a sink in the patient exam room, laminate flooring, ceiling A/C vent, wall mounted Hemodynamic monitoring equipment, and wall mounted oxygen/suction lines. Patient sedation will be limited to local anesthetics and/or oral anti-anxiety medications. Intravenous access will be obtained only for emergency resuscitative measures. Due to the low complication rate for this type of implant and practical limitations on the sample size, there are no formal hypotheses tested in this trial. This study will characterize all procedure-related adverse events that occur within 90 days of the implant procedure. Data will be collected at implant, 7-10 day post-op visit, and 90-day post-implant visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 is indicated for continuous arrhythmia monitoring with an Implantable Cardiac Monitor
- •Patient is willing to undergo implant in holding area setting with only local anesthetic and/or oral anti-anxiety medications for sedation (2 mg of Valium or Ativan) at patient request.
- •Patient is 18 years of age or older.
- •Patient is willing to provide informed consent and authorize disclosure of personal health information in accordance with state and national regulations.
排除标准
- •Patient has reduced immune function or is otherwise at high risk for infection
- •Patient has had a recent (within 30 days) or otherwise unresolved infection.
- •Patient is implanted or indicated for implant with a pacemaker, Implantable Cardiac Device (ICD), Cardiac Resyncronization Therapy (CRT) or hemodynamic monitoring system.
- •Patient is participating in another clinical trial that may have an impact on the trial endpoints.
- •Patient has a super-therapeutic INR > 3.
- •Patient considered by Principal Investigator and/or sub-investigator to be inappropriate for the trial for any reason.
- •Patient's life expectancy is less than 1 year.
- •Patient is pregnant.
- •Patient has an unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure.
- •Inability to comply with planned trial procedures
结局指标
主要结局
Rate of procedure-related complications within 90 days of implant which require resolution by surgical intervention.
时间窗: 90 days post-implant.
-For this study there is no formal hypothesis or performance criterion tested for this objective. Instead, the rate of these complications will be characterized by computing a point estimate and one-sided upper 95% confidence interval for the rate of procedure-related complications requiring surgical intervention 90 days post-implant-
次要结局
- Resource utilization for LINQ ICM holding area implants.(90 Days Post Implant)
- Procedures utilized during LINQ ICM holding area implants.(90 Days Post Implant)
- Cost-effectiveness for LINQ ICM holding area implants.(90 days Post Implant)
- Device functionality post-implant through patient trial exit visit.(90 Days Post Implant)
- Techniques utilized during LINQ ICM holding area implants.(90 Days Post Implant)
研究者
Wilson Burke
Clinical Research Manager
Holy Cross Hospital, Florida