Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7,075
- 试验地点
- 201
- 主要终点
- 12 Month Kaplan-Meier Estimate of Major CIED Infection Rate
研究概览
简要总结
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is willing to sign and date the study patient informed consent (PIC) form
- •Patient is at least 18 years of age and meets age requirements per local law
- •Patient is planned to undergo at least one of the following:
- •a. Patient has existing cardiac implantable electronic device (CIED) and is undergoing implantable pulse generator (IPG) (including cardiac resynchronization therapy pacemaker [CRT-P]), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) replacement or upgrade with a new Medtronic generator
- •i. Subjects planned to have leads added, or extracted and added for upgrades can be enrolled OR
- •b. Patient will undergo a de novo Medtronic CRT-D system implant per approved indications
- •c. Patient has existing study eligible Medtronic CIED in which the pocket was not accessed within the last 365 days, and is undergoing pocket or lead revision
- •Willing to provide the contact information for the physician who provides followup for his/her CIED
- •Willing and able to comply with scheduled follow-up and study related activities
排除标准
- •Known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to implantation of the TYRX envelope.
- •Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone or equivalent.
- •Hemodialysis or peritoneal dialysis.
- •Prior Cardiac transplantation or existing Ventricular Assist Device (VAD).
- •Require long-term vascular access for any reason.
- •Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
- •Physical, clinical, or laboratory signs or symptoms consistent with an active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia)
- •Systemic lupus erythematous, because minocycline has been reported to aggravate this condition
- •Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within 7 days prior to device procedure
- •Participation in another study that may confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
结局指标
主要结局
12 Month Kaplan-Meier Estimate of Major CIED Infection Rate
时间窗: Implant to 12 months
CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis. Major CIED infections are defined as a CIED infection resulting in one or more of the following: * CIED system removal * Any invasive procedure (e.g. pocket opened) without system removal * Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage * Death
次要结局
- Kaplan-Meier Estimate of a Major Infection Throughout Follow-up(Throughout study follow-up Kaplan-Meier Estimate is at 36 Months)
- 12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection(Implant to 12 months)
- 12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication(Implant to 12 months)