Reveal® In-Office Implants Study

Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 66 人开始时间: 2010年8月最近更新: 2018年2月28日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 66
主要终点: Procedure-related Complications Rate Requiring Resolution by Surgical Intervention

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to gather evidence about the safety and feasibility of performing the implant procedure for the Reveal Insertable Cardiac Monitor (ICM) in an office or clinic setting rather than the traditional hospital operating room, cardiac catheterization or electrophysiology (EP) laboratory setting.

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 Insertable Cardiac Monitor (ICM)
•Patient is willing to undergo implant in clinic setting with only local anesthetic and/or oral anti-anxiety medications for sedation
•Patient is 18 years of age or older
•Patient is willing and able to provide consent and authorize the use and disclosure of health information
•Patient is willing and able to comply with the protocol including the required follow-up

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 Cardioverter-Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), or hemodynamic monitoring system
•Patient is participating in another clinical study that may have an impact on the study endpoints
•Patient's life expectancy is less than 1 year
•Patient is pregnant
•Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure

结局指标

主要结局

Procedure-related Complications Rate Requiring Resolution by Surgical Intervention

时间窗: From Implant to 90 days post-implant procedure

This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.

次要结局

Number of Participants Having Procedure-related Adverse Events(From Implant to 90 days post-implant procedure)
Techniques and Procedures Utilized During Reveal In-office Implants(At implant)
R-wave Amplitude Measurement(Implant procedure and 30 days post-implant procedure)
Surgical Staff Utilized for Reveal In-office Implants(At implant)
Physician Satisfaction With Reveal In-office Implants(At implant)

研究者

发起方

Medtronic Cardiac Rhythm and Heart Failure

申办方类型

Industry

责任方

Sponsor

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