CTSN Embolic Protection Trial
Purpose
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Conditions
- Delirium
- Ischemic Stroke
- Acute Kidney Injury
- Heart Valve Disease
- Coronary Artery Disease
Eligibility
- Eligible Ages
- Over 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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. - No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 7 days prior to randomization - Ability to provide informed consent and comply with the protocol
Exclusion Criteria
Exclusion Criteria: - 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 the planned procedure - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Patients will be randomized 1:1 to the embolic protection device or to a standard cannula in the OR immediately after sternotomy and confirmation by the surgical team of the patient's suitability for the proposed intervention (CardioGard embolic protection device).
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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). |
|
|
Placebo Comparator 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 |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Icahn School of Medicine at Mount Sinai
Detailed Description
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.