TYRX™ Pocket Health Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Morphology of device capsule tissue
研究概览
简要总结
Medtronic, Inc. is sponsoring the TYRX™ Pocket Health Study to evaluate the histological and morphometric parameters of the device capsule in participants who underwent a cardiovascular implantable electronic device (CIED) procedure with a TYRX™ Absorbable Antibacterial Envelope and are returning for a CIED replacement procedure.
详细描述
The TYRX™ Pocket Health Study is a prospective, multi-center, single arm, post-market non-interventional study. This global study is planned to be conducted in geographies including, but not limited to, the United States (US), Canada, and Europe, at approximately 5 to 10 centers and will enroll up to 35 subjects with analyzable tissue samples. All enrolled subjects must have an existing CIED (implantable pulse generator (IPG), cardiac resynchronization therapy pacemaker (CRT-P), implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)) that was implanted with the TYRX™ Absorbable Antibacterial Envelope and are returning for a clinically indicated CIED generator replacement without the planned addition of new or revision of existing leads.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Previously underwent a transvenous CIED implantation utilizing TYRX™ Absorbable Antibacterial Envelope and is returning for a CIED replacement procedure without planned addition of new or revision of existing leads at least 12 months from the prior CIED implant with use of TYRX™ Absorbable Antibacterial envelope (TYRX procedure of interest)
- •a. Participants with history of one or two prior CIED implantation(s) at current implant site can be included, provided there was no invasive intervention to the pocket since the TYRX procedure of interest, defined by Exclusion Criteria #2
- •Age is ≥ 18 years (or meets age requirements per local law) at time of enrollment
- •Procedure information from participant's TYRX procedure of interest can be obtained
- •Date of the TYRX procedure of interest
- •Received a TYRX™ Absorbable Antibacterial Envelope during TYRX procedure of interest
- •Provides signed and dated authorization and/or consent per institution and local requirements
- •Willing and able to comply with the protocol
排除标准
- •Active infection involving the CIED implant site (physical, clinical, or laboratory signs/symptoms consistent with an active infection at time of replacement procedure, including but not limited to pneumonia, urinary tract, cellulitis, endocarditis, or bacteremia)
- •Prior history of requiring invasive intervention to the pocket since the TYRX procedure of interest, including but not limited to lead revisions or CIED infection
- •Prior history of skin infection at CIED implant site since the TYRX procedure of interest
- •Returning for a CIED extraction, system upgrade, CIED replacement with planned lead addition and/or revision, planned lead revision, or pocket revision (e.g., pocket revision due to pain)
- •Currently has or requires a submuscular or right-sided CIED implantation, or a subcutaneous implantable cardioverter defibrillator (S-ICD)
- •Existing Ventricular Assist Device (VAD)
- •Currently receiving hemodialysis or peritoneal dialysis therapy
- •Current therapy with chronic oral immunosuppressive agents or ≥ 20mg/day of Prednisone (or equivalent)
- •Has medical condition or history that precludes participant from participation in the opinion of the Investigator (e.g., too superficial positioning of the CIED)
- •Pregnant or breastfeeding participant or participant of childbearing potential and who is not on reliable form of birth regulation method or abstinence
- •Legally incompetent or otherwise vulnerable
- •Participation in another study that may potentially confound the results of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic
结局指标
主要结局
Morphology of device capsule tissue
时间窗: CIED Replacement Procedure
Measurement of capsule wall thickness (measured in millimeters, mm) in tissue sample
Histology of device capsule tissue
时间窗: CIED Replacement Procedure
Histopathologic examination of tissue sample for extent of fibrosis, inflammation, vascularization, calcification, and adhesions, based on ordinal scoring scale
次要结局
未报告次要终点