NCT06115980招募中不适用
First in Man, Open-label, Multi Center Safety and Preliminary Performance of Xtrac O.S. System for Lead Extraction.
Xtrac O.S.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年8月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate safety related to the lead extraction procedure, or the extraction tool
研究概览
简要总结
This is an open label, interventional, feasibility, prospective, multicenter, clinical trial of lead extraction. The Xtrac O.S. system is intended for transvenous removal of pacing or defibrillator leads, having an inner lumen, through a superior approach.
A total of 15 patients, who are scheduled for CIED lead extraction, will be recruited in order to ensure a total of at least 10 patients finishing the study procedures and follow up.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or Female patients, 18-85 years old.
- •Patients must understand the procedures and methods of this study and be willing to sign the informed consent form and to complete the trial in strict accordance with clinical trial protocol.
- •Scheduled for a CIED lead extraction upon current guidelines.
- •Lead implant duration more than 1 year and less than 5 years.
- •Patient must be SARS-CoV-2 negative and without Covid-19 signs and symptoms, prior to enrollment.
- •Patients are classified as ASA II/III.
- •Leads with external diameter of 7Fr-9Fr.
排除标准
- •Patient age > 85 years old.
- •Hemodynamic instability.
- •Class IV NYHA heart failure.
- •Contrast allergy.
- •Patients felt to be high risk due to degree of acute illness or systemic comorbidities.
- •Patients who are placed on a heparin bridge, and are felt to be high risk for even brief discontinuation of anticoagulation
- •Pregnant or lactating.
- •Participating in another clinical study.
- •Eligibility will be determined by the PI and investigators based on the exclusion/inclusion criteria, current medical status and evaluation of the procedure risks mitigation.
结局指标
主要结局
To evaluate safety related to the lead extraction procedure, or the extraction tool
时间窗: 0 to 30 days post-lead extraction
To collect and evaluate device- and procedure-related adverse events.
次要结局
- To assess the ease of use, duration of the procedure and the physician satisfaction by questions by a Likert scale(During procedure)
- To evaluate the rate of complete procedural success of removal leads implanted for more than 1and up to 5 years(Acute setting (during the surgical procedure))
- To evaluate the rate of clinical procedural success(Acute setting (during the surgical procedure))
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1106 in Advanced Solid TumorsSolid TumorsNCT05650242Shandong Boan Biotechnology Co., Ltd177
进行中（未招募）
1 期
This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy with Envafolimab in Patients with Advanced or Metastatic Solid Tumors.Advanced or Metastatic Solid TumorsNCT06074497Kangabio AUSTRALIA LTD PTY54
Unknown
1 期
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate in Lateral Epicondylitis (Tennis Elbow)Lateral Epicondylitis (Tennis Elbow)NCT01668862Kasiak Research Pvt. Ltd.20
进行中（未招募）
1 期
Tuvusertib (M1774) in Participants With Metastatic or Locally Advanced Unresectable Solid Tumors (DDRiver Solid Tumors 301)Metastatic or Locally Advanced Unresectable Solid TumorsNCT04170153EMD Serono Research & Development Institute, Inc.161
终止
1 期
Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid TumorsAdvanced Solid TumorsNCT05718219Jiangsu Simcere Pharmaceutical Co., Ltd.49