NCT04657718撤回不适用
CLAIM: Using the KODEX-EPDTM System to Guide PaCing Lead Placements, A First In Man Study
EPD Solutions, A Philips Company0 个研究点开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Primary Safety Endpoint - Incidence of intra -and Perioperative complications
研究概览
简要总结
Prospective, multi-center (2-3 sites), non-randomized, open label, single arm 3 phase study:
- Phase 1 or Evaluation Phase: Where the KODEX-EPD System will be used to exclusively monitor the entire implantation procedure; the KODEX-EPD system will not be used for guidance during the lead implantation workflow.
- Phase 2 - KODEX-EPD-assisted Phase: Where the KODEX-EPD system will be used for cardiac imaging acquisition, guidance during lead implantation in conjunction with fluoroscopic imaging
- Phase 3 - KODEX-EPD-guided Phase: Where the KODEX_EPD System will be used as the leading imaging modality during the lead implantation workflow. Fluoro can be used;
- up until the part of the lead implantation workflow that is the scope of this investigation.
- As a bailout, when the operator declares failure to attempt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients scheduled to undergo lead placement for cardiac pacing. Subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.
- •Inclusion Criteria:
- •Subject must be aged >18 years.
- •Subject must have signed a written iInformed Cconsent form to participate in the study, prior to any study related procedures.
- •Subject must be willing to comply with the protocol requirements.
- •Subject is scheduled for a de novo pacing lead implantation or system upgrade .
排除标准
- •Patients for whom previous CRT or conduction pacing implantation has failed.
- •Patients considered for leadless cardiac pacing system.
- •Patients undergoing a system revision for infection or malfunction.
- •Patients undergoing planned, urgent or emergency lead revision or lead extraction.
- •Subjects who have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
- •Patients included in a clinical registry or clinical trial for an investigational product.
- •Pregnant women.
结局指标
主要结局
Primary Safety Endpoint - Incidence of intra -and Perioperative complications
时间窗: 3 months
Incidence rate of intra -and Perioperative complications (bleeding, hematoma, cardiac tamponade, cardiac perforation , appearance of hemodynamic relevant arrhythmias requiring intervention)
Primary Feasibility Endpoint - Ability of imaging with permanent implantable leads and guidewires.
时间窗: time of procedure - 2-5 hours
The successful use of permanent implantable leads and guidewires for imaging with KODEX - EPD. Assessment of the ability of the KODEX-EPD system to create real time 3D images of the anatomy of the heart.
次要结局
- Procedure Time - per lead(time of procedure - 2-5 hours)
- Use of Contrast(time of procedure - 2-5 hours)
- Total procedure time(time of procedure - 2-5 hours)
- Lead implantation adjusted with Fluoroscopy(time of procedure - 2-5 hours)
- Fluoroscopy dose(time of procedure - 2-5 hours)
- Procedure Time - all leads(time of procedure - 2-5 hours)
- Right heart image(time of procedure - 2-5 hours)
- Fluoroscopy time(time of procedure - 2-5 hours)
研究者
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