DeliriumEMPRONCT06027788
CTSN Embolic Protection Trial
A study testing CardioGard Embolic Protection Cannula and Standard Aortic Cannula in people with Delirium and Ischemic Stroke, run by Icahn School of Medicine at Mount Sinai at 24 sites in 2 countries.
Trial summary
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Ischemic Stroke, Acute Kidney Injury
- What is being tested?
- CardioGard Embolic Protection Cannula and Standard Aortic Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 842 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 18 Sep 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States20 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Johns Hopkins Medicine
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22903
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
University of Maryland
College Park, Maryland, 20742
Duke University
Durham, North Carolina, 27710
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Keck Hospital of the University of Southern California
Los Angeles, California, 90033
West Virginia University
Morgantown, West Virginia, 26506
Ochsner Clinic
New Orleans, Louisiana, 70506
Columbia University Medical Center
New York, New York, 10032
Northwell Health
New York, New York, 21287
CHI St. Vincent Heart Institute
North Little Rock, Arkansas, 72117
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Maine Medical Center
Portland, Maine, 04102
Mayo Clinic
Rochester, Minnesota, 55905
Montefiore Medical Center
The Bronx, New York, 10467
Canada4 sites
London Health Sciences Centre
London, Ontario
Montreal Heart Institute
Montreal, Quebec
University of Ottawa Heart Institute
Ottawa, Ontario
Hôpital Laval
Québec, Quebec, QC G1V 4G5
About this study
Official title: Embolic Protection in Patients Undergoing High-Risk Valve Surgery
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
Read the 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.
SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies
The aims of this ancillary sub-study include:
- To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery.
- To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery.
Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months.
All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.
- Conditions
- Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease, Coronary Artery Disease
- Being tested
- CardioGard Embolic Protection Cannula, Standard Aortic Cannula
- Keywords
- Embolic Protection, Cardiac Surgery, CardioGard
- Medical subject headings
- Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioGard Embolic Protection CannulaDevice
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.
Standard Aortic CannulaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CardioGard Embolic Protection Cannula | Active comparator | 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). Receives: Device: CardioGard Embolic Protection Cannula |
| Standard Aortic Cannula | Placebo comparator | In patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice Receives: Device: Standard Aortic Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
The combined number of patients who experience clinical ischemic strokes and acute kidney injuries that have occurred within 3 days post-randomization.
Measured: within 3 days post-randomization
Number of patients who experience of death and delirium
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).
Measured: by 7 days post-randomization
Secondary outcomes (38)
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 3 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Measured: within 3 days post-randomization
Proportion of patients who experience a clinical ischemic stroke
The proportion of patients who experience a clinical ischemic stroke within 7 days will be compared between the two groups (i.e., standard cannula versus the CardioGard device).
Measured: within 7 days post-randomization
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 3 days post-randomization
Measured: within 3 days post-randomization
Number of patients with disabling clinical stroke
Number of patients with disabling clinical stroke within 7 days post-randomization
Measured: within 7 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.
Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.
These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Measured: within 3 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Neurological outcomes are assessed by National Institutes of Health stroke Scale (NIHSS) to compare the treatment outcomes of three types of service delivery models. The NIHSS is an 11-item impairment scale to evaluate neurologic outcome and degree of recovery.
Each item is scored between 0 and up to 4, total score ranges 0 (normal function) and a maximum possible score 42, with higher score indicating higher level of impairment.
These assessments will be administered by blinded neurology trainees or study coordinators who are certified to administer the assessments.
Measured: within 7 days post-randomization
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at baseline days.
The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.
5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6 - Dead.
Measured: at baseline
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 30 days.
The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.
5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6 - Dead.
Measured: at 30 days
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Number of patients with disabling clinical stroke as indicated by mRS score ≥2. mRS will be assessed at 90 days.
The scale runs from 0-6, running from perfect health without symptoms to death. A higher score indicates greater impairment.
0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to walk and attend own bodily needs without assistance.
5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6 - Dead.
Measured: at 90 days
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at presurgical baseline.
The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above was considered normal. Higher values represent a better outcome.
Measured: at baseline
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 90 days.
The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Measured: at 90 days
Montreal Cognitive Assessment (MoCA) Score
Global cognitive screening performance will be compared between groups and collected via the Montreal Cognitive Assessment (MoCA) - blind version at 12 months.
The MoCA scale is used for detecting cognitive impairment. The scores range between 0 to 30 points; a score of 26 or above is considered normal. Higher values represent a better outcome.
Measured: at 12 months
Oral Trail Making Test - Parts A and B (executive function)
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: at baseline
Oral Trail Making Test - Parts A and B (executive function)
The Trail Making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: at 90 days post-randomization
Oral Trail Making Test - Parts A and B (executive function)
The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient connects the "trail." If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Measured: baseline
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Measured: at 90 days post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
The WAIS-R Digit Span test assesses short term or working memory. The examinee listens to sequences of numbers orally and then repeats them as heard, in increasing order, and in reverse order. The raw scores for "digit span" range from a minimum of 2 to a maximum of 8. For this test, the longer the span the better the cognition; therefore, the higher score is the better outcome.
Measured: at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
The WAIS-R Digit Symbol Substitution Test (DSST) is a paper-and-pencil cognitive test that consist of number-symbol pairs. It requires the examinee to copy, into spaces below rows of numbers, the symbols that are paired to each number. The DSST score is the number of digits coded correctly in a 90-second test period
Measured: at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Measured: at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Measured: at 90 days post-randomization
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
The D-KEFS Verbal Fluency Test is comprised of three testing conditions: Letter Fluency, Category Fluency, and Category Switching. This test measures multiple aspects of verbal productivity and cognitive flexibility. It evaluates effectiveness of novel and semantic search strategies, and assesses flexibility in the implementation of word search strategies. There are three conditions in the test in which the examinee must say as many words as they can by letter, category, and category switching prompts.
Measured: at 12 months post-randomization
Incidence of Delirium
The incidence of delirium will be assessed daily by the Confusion Assessment Method (3D-CAM or CAM-ICU) scale, or by the presence of a delirium adverse event, during the first 7 days post-randomization.
The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4 and involves the presence/absence of delirium, but not its severity. Any error or behavioral observation consistent with a delirium feature means that feature is present.
Measured: first 7 days post-randomization
Duration of Delirium
The duration of delirium will be measured as the number of days with positive CAM assessments or delirium adverse events by 7 days post-randomization.
The CAM consists of 4 features: 1-Onset, 2-Inattention, 3-Disorganized thinking, and 4-altered level of consciousness. The diagnosis of delirium by CAM is based on the presence of features 1 and 2, and either 3 or 4.
Measured: first 7 days post-randomization
Severity of Delirium
The severity of delirium will be measured during daily screening using standardized algorithms for extracting symptom severity from the 3D-CAM and CAM-ICU.
Measured: first 7 days post-randomization
Number of Patients who experience Acute kidney injury (AKI)
Number of Patients who experience Acute kidney injury will be assessed within 7 days post-randomization.
Measured: within -7 days post-randomization
All-cause mortality
All-cause mortality within 90 days post-randomization will be assessed.
Measured: within 90 days post-randomization
All-cause mortality
All-cause mortality within 12-months post-randomization will be assessed.
Measured: within 12 months post-randomization
Length of Index Hospitalization
Overall length of stay for the index hospitalization post-randomization will be measured and broken down by days spent in the ICU versus days not in the ICU.
Measured: at hospital discharge, up to 30 days
Discharge disposition
Discharge disposition
Measured: at hospital discharge, up to 30 days
Readmissions rates
Readmission rates will be calculated for the first 90 days following randomization. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Measured: first 90 days
Readmissions rates
Readmission rates will be calculated for the duration of follow-up, out to 1 year. Hospitalizations will be classified for all causes including for cardiovascular readmissions.
Measured: up to 1 year post-randomization
Days Alive out of Hospital
Days alive out of hospital and nursing/rehab facilities within 90 days after randomization
Measured: within 90 days post-randomization
Actigraphy
Actigraphy data will be collected for a period of 7 days prior to the index surgical procedure. Actigraphic monitoring employs an accelerometer the size of a watch, which each study patient will wear on the wrist.
Collected for participants in substudy.
Measured: 7-day period prior to index surgical procedure and Day 1 post index surgical procedure through hospital discharge
Amount of Circadian Light
A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to monitor the total amount of circadian light received by the patient.
Collected for participants in substudy.
Measured: 7-day period prior to index surgical procedure
Photopic Light Levels
A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to calculate photopic light levels
Collected for participants in substudy.
Measured: 7-day period prior to index surgical procedure
Circadian Stimulus Values
A Speck light meter will be worn as a pendant while awake for a period of 7 days prior to surgery. Light measurements from light meters used as pendants are the closest to light measurements at eye level. The light meter will also be used to calculate circadian stimulus values,
Collected for participants in substudy.
Measured: 7-day period prior to index surgical procedure
Richards-Campbell Sleep Questionnaire
Patients who are able to do so will be asked to fill out the Richards-Campbell Sleep Questionnaire (RCSQ), which is a brief 2-minute questionnaire designed for patient use in the ICU. Full score range from 0-100, with higher score indicating better sleep.
Collected for participants in substudy.
Measured: Day 1 post index surgical procedure through patient discharge from the ICU (average ICU stay is 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start18 Sep 2023
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 842 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Annetine Gelijns, Icahn School of Medicine at Mount Sinai
- Investigators
- Annetine C. Gelijns, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiSteve Messe, MD, Principal investigator, University of PennsylvaniaAlexander Iribarne, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027788
- Sponsor's protocol ID
- STUDY-23-00417
- Other IDs
- 5U01HL088942-16
- Acronym
- EMPRO
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolic Protection in Patients Undergoing High-Risk Valve Surgery
- ClinicalTrials.gov ID
- NCT06027788
- Acronym / sponsor ID
- EMPRO / STUDY-23-00417
- Conditions
- Delirium, Ischemic Stroke, Acute Kidney Injury, Heart Valve Disease, Coronary Artery Disease
- Keywords
- Embolic Protection, Cardiac Surgery, CardioGard
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 842 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
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.
SUBSTUDY Sleep Disturbance Ancillary Sub-Study - Patients undergoing surgery for valvular heart disease (VHD) are at high risk for adverse events, including high rates of post-operative delirium (POD). Should circadian disruption be found to be an important predictor in this high-risk population, safe, low cost, and easy to administer therapies to regulate circadian rhythm such as light therapy could be evaluated in future studies
The aims of this ancillary sub-study include:
- To investigate the association between short sleep duration, less sleep regularity, and greater circadian rhythm disruption prior to surgery and POD within 7 days of VHD surgery.
- To investigate the association between short sleep duration, less sleep regularity and greater circadian rhythm disruption (reduced melatonin and cortisol amplitudes) after surgery and POD within 7 days of VHD surgery.
Approximately 300 EMPRO trial participants will be enrolled into the ancillary study. The study is being conducted in highly experienced clinical centers in the U.S. and Canada. The estimated enrollment period is 12-15 months.
All eligible and consented patients in the parent EMPRO trial will be offered enrollment in this ancillary study through the parent trial consent process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| CardioGard Embolic Protection Cannula | Active comparator | Device: CardioGard Embolic Protection CannulaIn 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). |
| Standard Aortic Cannula | Placebo comparator | Device: Standard Aortic CannulaIn patients assigned to the standard cannula group, standard cannulation techniques are performed using any standard aortic cannula of the surgeon's choice |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 60 years
- Planned de novo or redo:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioGard Embolic Protection CannulaThe 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. | Device | CardioGard Embolic Protection Cannula |
| Standard Aortic CannulaAn 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. | Device | Standard Aortic Cannula |
Primary outcome
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI)
Time frame: 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 delirium
Time frame: by 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).
38 secondary outcomes
Proportion of patients who experience a clinical ischemic stroke
Time frame: within 3 days post-randomization
Proportion of patients who experience a clinical ischemic stroke
Time frame: within 7 days post-randomization
Number of patients with disabling clinical stroke
Time frame: within 3 days post-randomization
Number of patients with disabling clinical stroke
Time frame: within 7 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Time frame: within 3 days post-randomization
Neurological outcomes assessed by National Institutes of Health Stroke Scale (NIHSS)
Time frame: within 7 days post-randomization
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Time frame: at baseline
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Time frame: at 30 days
Number of patients with disabling clinical stroke determined by modified Rankin Scale (mRS) score ≥2
Time frame: at 90 days
Montreal Cognitive Assessment (MoCA) Score
Time frame: at baseline
Montreal Cognitive Assessment (MoCA) Score
Time frame: at 90 days
Montreal Cognitive Assessment (MoCA) Score
Time frame: at 12 months
Oral Trail Making Test - Parts A and B (executive function)
Time frame: at baseline
Oral Trail Making Test - Parts A and B (executive function)
Time frame: at 90 days post-randomization
Oral Trail Making Test - Parts A and B (executive function)
Time frame: at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Time frame: baseline
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Time frame: at 90 days post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Span (auditory-verbal attention)
Time frame: at 12 months post-randomization
Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol Substitution Test (processing speed)
Time frame: at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Time frame: at baseline
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Time frame: at 90 days post-randomization
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (verbal fluency/executive function)
Time frame: at 12 months post-randomization
Incidence of Delirium
Time frame: first 7 days post-randomization
Duration of Delirium
Time frame: first 7 days post-randomization
Severity of Delirium
Time frame: first 7 days post-randomization
Number of Patients who experience Acute kidney injury (AKI)
Time frame: within -7 days post-randomization
All-cause mortality
Time frame: within 90 days post-randomization
All-cause mortality
Time frame: within 12 months post-randomization
Length of Index Hospitalization
Time frame: at hospital discharge, up to 30 days
Discharge disposition
Time frame: at hospital discharge, up to 30 days
Readmissions rates
Time frame: first 90 days
Readmissions rates
Time frame: up to 1 year post-randomization
Days Alive out of Hospital
Time frame: within 90 days post-randomization
Actigraphy
Time frame: 7-day period prior to index surgical procedure and Day 1 post index surgical procedure through hospital discharge
Amount of Circadian Light
Time frame: 7-day period prior to index surgical procedure
Photopic Light Levels
Time frame: 7-day period prior to index surgical procedure
Circadian Stimulus Values
Time frame: 7-day period prior to index surgical procedure
Richards-Campbell Sleep Questionnaire
Time frame: Day 1 post index surgical procedure through patient discharge from the ICU (average ICU stay is 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Delirium
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioGard Embolic Protection Cannula and Standard Aortic Cannula in people with Delirium and Ischemic Stroke, run by Icahn School of Medicine at Mount Sinai at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experience ischemic stroke and Acute Kidney Injury (AKI) (time frame: within 3 days post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.