Embolic Protection in Patients Undergoing High-Risk Valve Surgery
Icahn School of Medicine at Mount Sinai
Summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
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 protect…
Eligibility
- Age range
- 60+ years
- Sex
- All
- 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. * Valve sparing aortic r…
Interventions
- DeviceCardioGard Embolic Protection Cannula
The CardioGard embolic protection cannula is a device that combines the function of a standard aortic cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The device is comprised of 2 hollow tubes. The first tube is the standard main forward-flow tube to return oxygenated blood to the patient's aorta. The second tube attached to an existing bypass vent port, is a novel element located posteriorly to the main tube; its function is to facilitate blood and particle suction by directing the blood back to the reservoir of the coronary bypass machine, while the retrieved embolic debris is eliminated through the filter of the venous reservoir.
- DeviceStandard Aortic Cannula
An aortic cannula is a device that is used routinely during cardiac surgery to return oxygenated blood from the cardiac bypass machine into the patient's aorta.
Locations (28)
- CHI St. Vincent Heart InstituteNorth Little Rock, Arkansas
- Keck Hospital of the University of Southern CaliforniaLos Angeles, California
- Emory UniversityAtlanta, Georgia
- Indiana UniversityBloomington, Indiana
- Indiana Ohio HeartFort Wayne, Indiana
- Ochsner ClinicNew Orleans, Louisiana