CTSN Embolic Protection Trial

Overview

About this study

The purpose of this study is to analyze the effectiveness and safety of an embolic protection device compared to a standard aortic cannula to reduce the effects of death, clinical stroke, delirium and acute kidney injury in high-risk valve surgery patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/28/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Tang, M.D., Ph.D.

Open for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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