A Multi-Center Registry Evaluating Participants Who Receive CanGaroo® Envelope or No Envelope During CIED Implantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Elutia Inc.
- 入组人数
- 500
- 试验地点
- 23
- 主要终点
- Association between participant characteristics and outcomes
研究概览
简要总结
A Multi-Center Registry Evaluating Participants Who Receive CanGaroo Envelope or No Envelope During their CIED Implantation
详细描述
This prospective, multi-center study will enroll up to 500 participants who are undergoing their initial CIED implant with either a CanGaroo envelope or no envelope.
Once a participant is enrolled in one of the two cohorts, each participant will have their medical history data reviewed and data will be recorded in the CRF including baseline demographics, medications, and diagnoses.
The details of the CIED procedure including any complications/AEs that occur during the procedure will be captured on the appropriate CRF.
Information collected at the follow-up visits will include documentation of post-procedure status, including any complications, adverse events, or revision/reoperation procedures that occur during the follow-up period. This information will also be collected for any unscheduled follow-ups, visits, or care encounters that occur up to 3 months post-procedure. For participants that agree and qualify for optional long-term follow-up, the same information will be collected at additional follow-up points every six months for up to five years.
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
- •Participants for whom this is their first CIED implantation at a particular anatomical site.
- •Participants with a history of prior CIED implants at other anatomical sites than the current site can be included, provided that the planned implant location for the current CIED procedure is the first implant procedure at that site.
- •Participants aged 18 years or older at time of enrollment.
- •Participant is able and agrees to provide written informed consent and use of PHI.
排除标准
- •Participants who have had one or more prior CIED procedures (implantations or revisions) at the current device implant site.
- •Participants under the age of 18 at time of enrollment.
结局指标
主要结局
Association between participant characteristics and outcomes
时间窗: 3 months post-procedure
Cohort comparison of clinically significant factors such as physical and demographic characteristics, medical history risk factors related to post-procedure events, and associations with outcomes and events.
Association between CanGaroo envelope use and CIED implant-related outcomes and events.
时间窗: 3 months post-procedure
Cohort comparison of clinically significant events such as infection, wound healing issues, CIED migration, CIED erosion, or a revision/reoperation procedure.
次要结局
未报告次要终点