Evaluation of a new embolic protection device in high-risk heart valve surgery patients
Embolic Protection in Patients Undergoing High-Risk Valve Surgery
This study is testing a new device to see if it can help older patients having heart valve surgery avoid complications like strokes and kidney problems compared to a standard device.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 842 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 28 sites (North Little Rock, Arkansas and 27 other locations) |
| Trial ID | NCT06027788 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multicenter, randomized controlled trial assessing the effectiveness and safety of the CardioGard embolic protection cannula compared to a standard cannula in patients aged 60 and older undergoing valve surgery. Participants will be randomly assigned to receive either the CardioGard device or a standard cannula immediately after surgical confirmation of their eligibility. The trial will enroll patients over a 30-month period, with follow-up lasting 12 months post-procedure to evaluate outcomes related to delirium, ischemic stroke, acute kidney injury, and other complications. The randomization process will be centrally controlled and stratified by surgical site and procedure type.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 60 and older who are scheduled for valve surgery with or without coronary artery bypass grafting.
Not a fit: Patients with a history of clinical stroke within the last three months or significant neurological impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly reduce the incidence of complications such as stroke and kidney injury in high-risk heart valve surgery patients.
How similar studies have performed: Previous studies have shown promise with embolic protection devices in cardiac procedures, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 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 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
Where this trial is running
North Little Rock, Arkansas and 27 other locations
- CHI St. Vincent Heart Institute — North Little Rock, Arkansas, United States (Recruiting)
- Keck Hospital of the University of Southern California — Los Angeles, California, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Indiana University — Bloomington, Indiana, United States (Not_yet_recruiting)
- Indiana Ohio Heart — Fort Wayne, Indiana, United States (Recruiting)
- Ochsner Clinic — New Orleans, Louisiana, United States (Recruiting)
- Maine Medical Center — Portland, Maine, United States (Recruiting)
- Johns Hopkins Medicine — Baltimore, Maryland, United States (Recruiting)
- University of Maryland — College Park, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
- New York Presbyterian-Cornell Medical Center — New York, New York, United States (Not_yet_recruiting)
- NYU Langone Hospital Brooklyn — New York, New York, United States (Recruiting)
- Northwell Health — New York, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University Hospitals — Cleveland, Ohio, United States (Not_yet_recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Not_yet_recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Not_yet_recruiting)
- Hôpital Laval — Québec, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Annetine C. Gelijns, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Claudia Merlin
- Email: Claudia.merlin@mountsinai.org
- Phone: 917-494-2387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.