Embolic Protection in Patients Undergoing High-Risk Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 842
- 试验地点
- 56
- 主要终点
- Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
研究概览
简要总结
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
详细描述
This is a prospective, multicenter, randomized controlled clinical trial that will evaluate the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula. The enrollment period is expected to last 30 months, and all patients will be followed for 12 months post procedure.
RANDOMIZATION Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the operating room (OR) immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device). Randomization will be with equal allocation and stratified by site and by procedure (i.e., isolated valve surgery or combined procedures, such as double valve or valve plus coronary artery bypass grafting, CABG). The randomization assignment will be controlled centrally and performed through a web-based data collection system that automates the delivery of the randomization codes. From the point of treatment assignment, primary efficacy will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignments at randomization regardless of whether or not they actually received the treatment to which they were assigned.
STUDY POPULATION The patient population for this trial consists of patients age ≥ 60 undergoing different types of valve surgery with or without CABG via full or minimal-access sternotomy using legally marketed valve(s). Specific inclusion and exclusion criteria are listed below. All patients who meet the eligibility criteria may be included in the study regardless of gender, race, or ethnicity.
SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies
The aims of this ancillary sub-study include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The nature of the study precludes masking surgeons from treatment assignment. Investigators will, however, be blinded to all data from other clinical sites, except serious unexpected adverse events possibly or probably related to the intervention for Institutional Review Board (IRB)/Research Ethics Board (REB) reporting purposes. Patients will be blinded as to treatment assignment. All neurocognitive scoring and delirium assessments will be analyzed by neurocognitive core laboratory personnel who will be blinded to treatment assignment and clinical outcomes.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Planned de novo or redo:
- •Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
- •Mitral valve replacement (MVR) ± CABG
- •Mitral Valve Repair + CABG,
- •Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure.
- •Valve sparing aortic root replacement (David procedure)
- •Valve sparing aortic root replacement (David procedure)
- •No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization
- •Ability to provide informed consent and comply with the protocol
排除标准
- •History of clinical stroke within 3 months prior to randomization
- •Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
- •Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening/baseline NIHSS score conducted prior to the catheterization
- •Active endocarditis at time of randomization with vegetation criteria
- •Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
- •Participation in an interventional (drug or device) trial
- •Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
- •Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
- •Planned concomitant carotid endarterectomy during index surgical procedure
研究组 & 干预措施
CardioGard Embolic Protection Cannula
In patients assigned to the embolic protection device group, the CardioGard Embolic Protection Cannula is used instead, according to the manufacturer's instructions for use (IFU).
干预措施: CardioGard Embolic Protection Cannula (Device)
Standard Aortic Cannula
In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice
干预措施: Standard Aortic Cannula (Device)
结局指标
主要结局
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
时间窗: within 3 days post-randomization
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
Number of patients who experience of death and delirium
时间窗: by 7 days post-randomization
The combined number of patients who experience death and delirium by 7 days post-randomization (with a blanking period for delirium of days 1 and 2 post-operatively).
次要结局
- Proportion of patients who experience a clinical ischemic stroke(within 7 days post-randomization)
- Number of patients with disabling clinical stroke(within 7 days post-randomization)
- Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)(within 7 days post-randomization)
- Montreal Cognitive Assessment (MoCA) Score(at 12 months)
- Oral Trail Making Test - Parts A and B (executive function)(at 12 months post-randomization)
- Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)(at 12 months post-randomization)
- Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)(at baseline)
- Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)(at 12 months post-randomization)
- Incidence of Delirium(first 7 days post-randomization)
- Duration of Delirium(first 7 days post-randomization)
- Severity of Delirium(first 7 days post-randomization)
- Number of Patients who experience Acute kidney injury (AKI)(within -7 days post-randomization)
- All-cause mortality(within 12 months post-randomization)
- Length of Index Hospitalization(at hospital discharge, up to 30 days)
- Discharge disposition(at hospital discharge, up to 30 days)
- Readmissions rates(up to 1 year post-randomization)
- Days Alive out of Hospital(within 90 days post-randomization)
- Actigraphy(7-day period prior to index surgical procedure and Day 1 post index surgical procedure through hospital discharge)
- Amount of Circadian Light(7-day period prior to index surgical procedure)
- Photopic Light Levels(7-day period prior to index surgical procedure)
- Circadian Stimulus Values(7-day period prior to index surgical procedure)
- Richards-Campbell Sleep Questionnaire(Day 1 post index surgical procedure through patient discharge from the ICU (average ICU stay is 3 days))
- Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2(at 90 days)
研究者
Annetine Gelijns
Professor of Health Policy, Chair Department of Health Evidence & Policy
Icahn School of Medicine at Mount Sinai