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| ID | Type | Description | Link |
|---|---|---|---|
| 2U01HL088942-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula or 2) to the treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embol-X Embolic Protection Device | Active Comparator | The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. |
|
| CardioGard Cannula | Active Comparator | The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. |
|
| Standard Cannula | No Intervention | Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embol-X Embolic Protection Device | Device | per the manufacturer's instructions for use (IFU). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction | freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting > 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions. | up to 10 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury | The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery. | up to 30 days |
| Number of Patients With Clinically Apparent Stroke at 7 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annetine C Gelijns, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Richard Weisel, MD | Toronto General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35483981 | Derived | Messe SR, Overbey JR, Thourani VH, Moskowitz AJ, Gelijns AC, Groh MA, Mack MJ, Ailawadi G, Furie KL, Southerland AM, James ML, Moy CS, Gupta L, Voisine P, Perrault LP, Bowdish ME, Gillinov AM, O'Gara PT, Ouzounian M, Whitson BA, Mullen JC, Miller MA, Gammie JS, Pan S, Erus G, Browndyke JN; Cardiothoracic Surgical Trials Network (CTSN) Investigators. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2024 Feb;167(2):624-633.e4. doi: 10.1016/j.jtcvs.2022.01.053. Epub 2022 Mar 18. | |
| 30007783 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Embol-X Embolic Protection Device | The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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Not provided
Not provided
Not provided
| CardioGard Cannula | Device | CardioGard Cannula, per the manufacturer's instructions for use (IFU). |
|
|
The number of patients who experience a clinically apparent stroke by 7 days post-op |
| at 7 days |
| Presence of Radiographic Infarcts | The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners | up to 10 days |
| Total Infarct Volume | Total infarct volume measured on day 7 dwMRI. | Day 7 |
| Decline in Overall Neurocognition | Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days | Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days | Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Decline in Neurocognitive Function in the Executive Function Domain at 90 Day | Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days | Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days | Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days | Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | baseline and 90 days |
| Modified Rankin Scale >2 at 90 Days | The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
| 90 days |
| Barthel Index <= 80 | An overall score has full range from 0 to 100, with higher scores indicating greater independence. | 90 days |
| Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days | 7 days |
| Mortality by 90 Days | Incidence of all-cause mortality | up to 90 days |
| Length of Stay for Index Hospitalization | up to 90 days |
| Hospital Readmissions | Rate of hospital readmissions | up to 90 days |
| Quality of Life - Physical Health Composite | Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10. | at 90 days |
| Quality of Life - Mental Health Composite | Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10. | at 90 days |
| Number of Participants With Emboli Captured | Assessed by the presence of any debris captured in filter of embolic protection device | day 1 |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| NIH Heart Center at Suburban Hospital | Bethesda | Maryland | 20814 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Montefiore Einstein Heart Center | The Bronx | New York | 10467 | United States |
| Mission Hospital | Asheville | North Carolina | 28801 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Baylor Research Institute | Plano | Texas | 75093 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| University of Alberta Hospital | Edmonton | Alberta | T6G2B7 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Institut Universitaire de Cardiologie de Quebec (Hopital Laval) | Québec | Quebec | G1V 4G5 | Canada |
| Derived |
| Crestanello JA. "Not in my brain": The use of embolic protection devices to prevent brain embolization during cardiovascular procedures. J Thorac Cardiovasc Surg. 2018 Dec;156(6):e205-e206. doi: 10.1016/j.jtcvs.2018.05.114. Epub 2018 Jun 23. No abstract available. |
| 28787505 | Derived | Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O'Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O'Gara PT, Messe SR; Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479. |
| CardioGard Cannula |
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU). |
| FG002 | Standard Cannula | Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Embol-X Embolic Protection Device | The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU). |
| BG001 | CardioGard Cannula | The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU). |
| BG002 | Standard Cannula | Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction | freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting > 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | up to 10 days post procedure |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury | The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery. | Three patients withdrew prior to day 30 and are not included in the denominators | Posted | Count of Participants | Participants | up to 30 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Clinically Apparent Stroke at 7 Days | The number of patients who experience a clinically apparent stroke by 7 days post-op | Two patients withdrew prior to day 7 | Posted | Count of Participants | Participants | at 7 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Presence of Radiographic Infarcts | The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners | Denominator includes all patients with day 7 MRI | Posted | Count of Participants | Participants | up to 10 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Infarct Volume | Total infarct volume measured on day 7 dwMRI. | Analysis population includes all those with dwMRI at 7 days | Posted | Median | Inter-Quartile Range | mm^3 | Day 7 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Decline in Overall Neurocognition | Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
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| Secondary | Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days | Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
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| Secondary | Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days | Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
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| Secondary | Decline in Neurocognitive Function in the Executive Function Domain at 90 Day | Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
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| Secondary | Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days | Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
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| Secondary | Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days | Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days | Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score. | Posted | Count of Participants | Participants | baseline and 90 days |
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| Secondary | Modified Rankin Scale >2 at 90 Days | The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
| Posted | Count of Participants | Participants | 90 days |
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| Secondary | Barthel Index <= 80 | An overall score has full range from 0 to 100, with higher scores indicating greater independence. | Posted | Count of Participants | Participants | 90 days |
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| Secondary | Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days | Posted | Count of Participants | Participants | 7 days |
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| Secondary | Mortality by 90 Days | Incidence of all-cause mortality | Posted | Count of Participants | Participants | up to 90 days |
|
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| Secondary | Length of Stay for Index Hospitalization | Posted | Mean | Standard Deviation | days | up to 90 days |
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| Secondary | Hospital Readmissions | Rate of hospital readmissions | Posted | Number | rate per 100-patient-months | up to 90 days |
|
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| Secondary | Quality of Life - Physical Health Composite | Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10. | Posted | Mean | Standard Deviation | T-Score | at 90 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Quality of Life - Mental Health Composite | Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10. | Posted | Mean | Standard Deviation | T-Score | at 90 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Emboli Captured | Assessed by the presence of any debris captured in filter of embolic protection device | Emboli are not captured by the standard cannula and therefore no data are available for this group in this outcome measure | Posted | Count of Participants | Participants | day 1 |
|
90 Days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Embol-X Embolic Protection Device | The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath. Embol-X Embolic Protection Device: per the manufacturer's instructions for use (IFU). | 4 | 133 | 72 | 133 | 45 | 133 |
| EG001 | CardioGard Cannula | The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula. CardioGard Cannula: CardioGard Cannula, per the manufacturer's instructions for use (IFU). | 5 | 118 | 53 | 118 | 47 | 118 |
| EG002 | Standard Cannula | Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing. | 3 | 132 | 54 | 132 | 43 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury - Stage 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute Kidney Injury - Stage 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute Kidney Injury - Stage 3 | Renal and urinary disorders | Systematic Assessment |
| ||
| Bleeding - Transfusion > 5 units RBC <24 hours following surgery | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bleeding - Re-operation for hemorrhage or tamponade | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias - Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias - Sustained ventricular arrhythmia requiring defibrillation or cardioversion | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrhythmias - Cardiac conduction abnormalities or sustained bradycardia requiring permanent | Cardiac disorders | Systematic Assessment |
| ||
| Pericardial Fluid Collection | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hepatic Dysfunction (Liver injury and Impaired Liver function) | Hepatobiliary disorders | Systematic Assessment |
| ||
| Major Infection - Localized Infection | Infections and infestations | Systematic Assessment |
| ||
| Major Infection - Endocarditis | Infections and infestations | Systematic Assessment |
| ||
| Major Infection - Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Myocardial Infarction - Non-Procedure Related | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction - Peri-CABG | Cardiac disorders | Systematic Assessment |
| ||
| Neurological Dysfunction- Transient Ischemic Attack - TIA | Nervous system disorders | Systematic Assessment |
| ||
| Neurological Dysfunction- Ischemic Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Neurological Dysfunction- Toxic Metabolic Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Neurological Dysfunction- Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Neurological Dysfunction- Other Neurological Dysfunction* | Nervous system disorders | Systematic Assessment |
| ||
| Renal Events (Renal Failure) | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Venous Thromboembolism Event - Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Venous Thromboembolism Event - Pulmonary Embolism | Vascular disorders | Systematic Assessment |
| ||
| Venous Thromboembolism Event - Other* | Vascular disorders | Systematic Assessment |
| ||
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Adrenal Insufficiency | Endocrine disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Aortic Valve Re-operation | Surgical and medical procedures | Systematic Assessment |
| ||
| Appendicitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Chest Pain | Cardiac disorders | Systematic Assessment |
| ||
| Cholecystitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Dysphagia with PEG tube placement | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Epistaxis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Fluid Overload | General disorders | Systematic Assessment |
| ||
| Foot Pain | General disorders | Systematic Assessment |
| ||
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Intra abdominal bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lung mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Orthostatic Hypertension | Cardiac disorders | Systematic Assessment |
| ||
| Pneumoperitoneum | Gastrointestinal disorders | Systematic Assessment |
| ||
| Post-pericardiotomy Syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Repair of Aorta | Surgical and medical procedures | Systematic Assessment |
| ||
| Severe TR requiring TV replacement | Cardiac disorders | Systematic Assessment |
| ||
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Small bowel obstruction/ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Weakness | General disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury - Stage 1 | Renal and urinary disorders | Systematic Assessment |
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| Cardiac Arrhythmias - Sustained supraventricular arrhythmia requiring drug treatment or cardioversio | Cardiac disorders | Systematic Assessment |
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| Major Infection - Localized Infection | Infections and infestations | Systematic Assessment |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annetine C. Gelijns, PhD | Icahn School of Medicine at Mount Sinai | 212-659-9568 | annetine.gelijns@mssm.edu |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D020520 | Brain Infarction |
| D020521 | Stroke |
| D058226 | Plaque, Atherosclerotic |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| United States |
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| Superiority |
| A sample size of 165 patients in each group ensured that each comparison had a power of approximately 90% to detect a between-group difference of 17.5% from an assumed control rate of 50% in the incidence of postoperative CNS infarcts. A single interim analysis was prespecified and performed. Based on the recommendation of the DSMB, randomization but not follow-up was halted due to low conditional power of observing any between-group differences for the primary endpoint. | Chi-squared | 0.84 | The primary end point analysis used an iterative hot-deck multiple imputation approach, assuming a nonignorable missing data mechanism. | Risk Difference (RD) | 1.3 | 2-Sided | 95 | -11.2 | 13.8 | The absolute difference in the percentage of patients with freedom from clinical or radiographic central nervous system (CNS) infarction was computed as Cardiogard minus control. | Superiority |
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Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
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