A Multi-Center Registry Evaluating EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Elutia Inc.
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Adverse Events/Complication Rates
研究概览
简要总结
A Multi-Center Registry Study Evaluating Participants Who Receive EluPro Antibiotic-Eluting BioEnvelope During CIED Implantation
详细描述
This prospective, multi-center registry study will enroll up to 100 participants who will receive an EluPro Antibiotic-Eluting BioEnvelope during their CIED procedure.
Participant data will be captured at several time points: Screening/Enrollment, day of Surgical Procedure, and at Wound Check (2-4 Weeks) 3, 6, and 12 months post-surgery, as well as any unscheduled visits up to 12 months post-surgery. Any follow-up visit can be completed via telephone/video if the participant is not scheduled to be seen in the office. Patient-reported outcomes such as implant site pain and satisfaction questionnaires shall be administered to participants at each follow-up visit.
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
- •Patient is undergoing implantation of EluPro with either a de novo CIED implantation or has an existing CIED and is undergoing CIED replacement or upgrade.
- •Patient is willing to comply with scheduled follow-up and study-related visits.
- •Patient is 18 years of age or older at the time of enrollment.
- •Patient agrees to provide written informed consent and use of PHI.
排除标准
- •Patient has a prior history of CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
- •Patient is exhibiting signs or symptoms consistent with any type of active infection (including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia).
- •Patient has Stage 4 or 5 kidney disease (eGFR <30 ml/min).
- •Patient requires long-term vascular access for any reason.
- •Patient is undergoing implantation of a CIED that does not fit completely into EluPro, preventing closure of the bioenvelope to secure the CIED.
- •Patient is currently on chronic immunosuppressive agents or ≥20mg/day of Prednisone or equivalent.
- •Patient has known allergy to minocycline or rifampin or their derivatives, or any other known contraindications to the implantation of EluPro.
- •Patient is participating in another clinical study that could impact the outcome and documented pre-approval from the study sponsor has not been obtained.
- •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.
结局指标
主要结局
Adverse Events/Complication Rates
时间窗: 12 Months
Determine the rates of adverse events and complications associated with the use of EluPro device envelope in real-world settings.
次要结局
未报告次要终点