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CardioGard Embolic Protection Trial for High-Risk Valve Surgery

This study is testing the CardioGard Embolic Protection Cannula, a device designed to capture debris during heart surgery, against a standard aortic cannula. The goal is to see if the CardioGard device can reduce the risk of complications like ischemic stroke (a type of stroke caused by a blood clot), acute kidney injury, death, and delirium (a state of confusion). You may be able to join if you are 60 years or older and are having certain heart valve surgeries. The study is looking for 842 participants, but its current recruitment status is unclear.

Study design
This is a multi-center, randomized study where participants will be assigned by chance to receive either the CardioGard Embolic Protection Cannula or a standard cannula. It aims to enroll 842 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
All patients will be followed for 12 months after their procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06027788

CTSN Embolic Protection Trial

Recruiting
NAAges 60+InterventionalPrevention
Icahn School of Medicine at Mount Sinai
~842 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:CardioGard Embolic Protection CannulaStandard Aortic Cannula

At a glance

Recruiting sites
20 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
Measured over within 3 days post-randomization
+1 more outcome measured

Conditions

Delirium
Ischemic Stroke
Acute Kidney Injury
Heart Valve Disease
Coronary Artery Disease

Explore related trials

Coronary Artery DiseaseValvular Heart Disorder

Where it's being run

28 sites across 19 states
New York5
Indiana2
Maryland2
Ohio2
Ontario2
Quebec2
Arkansas1
California1

Study leadership

  • Annetine C. Gelijns, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Steve Messe, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Alexander Iribarne, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Claudia Merlin
[email protected]
917-494-2387
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)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 deliriumby 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).