Tauropace Reduces Infection After Cardiac Electronic Implantable Device Implantation in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Major CIED infections occurring within Twelve months after index procedure
研究概览
简要总结
The main purpose of the study is to evaluate the ability of the Tauropace to reduce major cardiac implantable electronic device (CIED) infections through 12-months post-procedure following CIED in heart failure participants. The secondary endpoint is to prospectively characterize the performance of Tauropace in participants whose CIED system includes a transvenous RV defibrillation lead.
详细描述
TRICE-HF is a prospective, multi-center, post-market, interventional clinical study. The main purpose of the study is to evaluate the ability of the Tauropace to reduce major CIED infections through 12-months post-procedure following CIED in heart failure patients. The secondary endpoint is to prospectively characterize the performance of Tauropace in subjects whose CIED system includes a transvenous RV defibrillation lead. These features include the lead integrity alert (LIA), lead noise alert (LNA), RV pacing impedance, and high voltage (HV) pacing impedance to detect events that affect a RV lead's pacing, sensing, or defibrillation circuit lead system events (LSE).
The study will be conducted at up to 10 sites in Italy with up to 500 subjects enrolled.
The enrollment period is expected to start in November 2021 and to take approximately 12 months. Participants will be followed for a minimum of 12 months. Therefore, the anticipated study duration is approximately 24 months and subjects may be followed for up to 24 months depending on when they enroll in the study.
This study is a nonrandomized registry; hence no formal control group will be used. In order to compare our follow-up data, the investigators performed an electronic search of the PubMed and Embase, including all RCTs, retrospective or prospective studied that resulted in CIED infection rates.
The investigators excluded all studies that included patients with abdominal device implants.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 at least 18 years of age, willing to sign and date the study PIC form and is planned to undergo at least one of the following:
- •Patient suffering from heart failure (FE<35%) undergoing de novo single or dual-chamber ICD or CRT-D system implant according to the most recent European Society of Cardiology guidelines
- •Patient suffering from heart failure (FE<35%) with a pre-existing CIED and planned to undergo ICD or CRT-D replacement or upgrading.
- •Antibiotic prophylaxis before procedure, surgical preparation with alcoholic chlorhexidine or povidone-iodine, measures to avoid pocket haematoma (avoid heparin bridging, discontinue antiplatelets if possible excluding cardioaspirin) according to current guidelines.
排除标准
- •Life expectancy of < 12 months or planned to undergo heart transplantation within 6 months.
- •Prior history of CIED infection, including endocarditis, in the past 12 months.
- •Clinical or laboratory sign or symptoms of active infection
- •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
Major CIED infections occurring within Twelve months after index procedure
时间窗: 12 months
The primary study objective is to evaluate the rate of major CIED infections through 12-months post-procedure in high-risk patients. Major CIED infection will be defined as a device infection involving any part of the anatomy other than the incision or subcutaneous tissue, which was opened or manipulated during the CIED implantation operation, or as endocarditis defined according to the modified Duke Criteria, that resulted in CIED system removal, an invasive CIED procedure (e.g., pocket revision without removal), treatment with long-term antibiotic therapy (if the patient was not a candidate for system removal) with infection recurrence after discontinuation of antibiotic therapy, or death. CIED infections that will not meet one or more of the criteria for major infection will be classified as minor CIED infections.
次要结局
- Adverse events after cardiac implantable electronic device implantation(12 months)
研究者
Antonio Rapacciuolo
Principal Investigator, Clinical Professor
Federico II University