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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Children's Hospital Los Angeles | OTHER |
| Children's Hospital Colorado |
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Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
This is a Phase IIb trial to determine if the delivery of the autologous UCB-MNC product into the myocardium of the right ventricle of the heart at the time of Stage II surgical repair will provide an improvement in cardiac function, reaching growth and developmental milestones, and quality of life, while also providing a reduction in the cumulative days of hospitalization following Stage II surgical repair. Long-term improvement in cardiac function, reaching growth and developmental milestones, reaching Stage III surgical repair pre-op work-up, prolonging time to cardiac transplantation or death, and improving quality of life will also be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . |
|
| Control | Active Comparator | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous (self) mononuclear cells derived from umbilical cord blood | Biological | The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | baseline, 3 months post-Stage II surgery |
| Change in Right Ventricular Cardiac Function Measured by Circumferential Strain. | Right ventricular cardiac function as measured by echocardiogram that includes studies for circumferential strain. Measured by percent. | baseline, 3 months post-Stage II surgery |
| Change in Right Ventricular Cardiac Function Measured by Longitudinal Strain. | Right ventricular cardiac function as measured by echocardiogram that includes studies for longitudinal strain. Measured by percent. | baseline, 3 months post-Stage II surgery |
| Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | baseline, 12 months post-Stage II surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | baseline pre-op, hospital discharge from Stage II surgery (an average of 1-6 weeks) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of DMSO reaction (treatment arm only).
Parent(s) and/or legal guardian(s) unwilling to have their child participate or unwilling to follow the study procedures.
Severe chronic diseases at the discretion of the treating physician.
Extensive extra-cardiac syndromic features.
Known history of cancer.
Any of the following complications of his/her congenital heart disease:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Cetta, MD | Mayo Clinic | Principal Investigator |
| Harold M. Burkhart, M.D. | Children's Hospital Oklahoma University Medical Center | Principal Investigator |
| Joseph W. Rossano, M.D. | Children's Hospital of Philadelphia | Principal Investigator |
| David M. Overman, M.D. | Children's Minnesota | Principal Investigator |
| Ram Kumar Subramanyan, M.D., Ph.D. | Children's Hospital Los Angeles | Principal Investigator |
| James Jaggers, M.D. | Children's Hospital Colorado | Principal Investigator |
| Benjamin Peeler, M.D. | Ochsner Health System | Principal Investigator |
| Waldemar Carlo, M.D. | University of Alabama at Birmingham | Principal Investigator |
| James Tweddell, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital of Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40312733 | Derived | Gallego-Navarro C, Jaggers J, Burkhart HM, Carlo WF, Morales DL, Qureshi MY, Rossano JW, Hagen CE, Seisler DK, Peral SC, Nelson TJ. Autologous umbilical cord blood mononuclear cell therapy for hypoplastic left heart syndrome: a nonrandomized control trial of the efficacy and safety of intramyocardial injections. Stem Cell Res Ther. 2025 May 1;16(1):215. doi: 10.1186/s13287-025-04316-3. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Subjects were recruited from May 2019 through January 2022 from the following eight sites: Children's Hospital Colorado, Children's Hospital Los Angeles, Children's Hospital of Alabama, Children's Hospital of Philadelphia, Children's Hospitals and Clinics of Minnesota - Minneapolis, Cincinnati Children's Hospital Medical Center, Ochsner Medical Center Jefferson, and Oklahoma University Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2024 |
Not provided
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| OTHER |
| Children's Hospitals and Clinics of Minnesota | OTHER |
| Ochsner Health System | OTHER |
| Children's of Alabama | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
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|
| Stage II Surgical repair | Procedure | This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
| Cumulative Days of Hospitalization |
Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair. |
| 1-month post Stage II surgery |
| Change in Weight | Change in weight between baseline and 3-months post Stage II surgery. Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used. | baseline, 3-months post Stage II surgery |
| Change in Heart Rate | Change in heart rate between baseline and 3-months post Stage II surgery. Heart rate as measured at home by subject's caregiver as standard of care per subject's provider. Caregivers will be instructed by the site staff on the best way to perform. | baseline, 3-months post Stage II surgery |
| Change in Oxygen Saturation | Change in oxygen saturation between baseline and 3-months post Stage II surgery. Oxygen saturation as measured at home by subject's caregiver using the pulse oximetry device provided as standard of care by subject's provider. Caregivers will be instructed by the site to use the same pulse oximetry device for every home measurement of oxygen saturation. | baseline, 3-months post Stage II surgery |
| Change in Weight | Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used. | baseline, every 6 months post-Stage II surgery |
| Change in Arrhythmia and Heart Failure Medication | Changes in arrhythmia and heart failure medications will be recorded by caregiver on the concomitant medication diary throughout the subject's participation in the study starting at the time of consent. | 3-months post-surgery |
| Stage III Surgical Repair | The number of research subjects eligible for Stage III surgical repair | Stage III surgery pre-op, approx. 4 years |
| Total Time Until Listed for Cardiac Transplantation | The number of days between Stage II surgery and listed on cardiac transplantation list. | up to Stage III surgery pre-op, approx. 4 years |
| Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | baseline, Stage III surgery pre-op |
| Total Time Until Death | The number of days between Stage II surgery and death occurrence | approx 4 years |
| Cumulative Days of Hospitalization | Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair. | 3-months post Stage II surgery |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Ocshner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Children's Hospitals of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Cincinnati Children's Hospital and Medical Center | Cincinnati | Ohio | 45529 | United States |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| FG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
| COMPLETED |
|
| NOT COMPLETED |
|
All enrolled subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
| BG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
| BG002 | 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 | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Fractional Area Change (%) | 2 treatment subjects did not have a baseline FAC measurement recorded, due to poor Echo image. | Mean | Standard Deviation | percentage of area |
| ||||||||||||||
| Troponin T (ng/mL) | 8 treated and 4 control subjects did not have baseline Troponin, due to site error in collecting the values. | Mean | Standard Deviation | ng/mL |
|
| 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 | Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | All enrolled subjects with both a baseline and 3-month Fractional Area Change value as assessed by Echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of area | baseline, 3 months post-Stage II surgery |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Right Ventricular Cardiac Function Measured by Circumferential Strain. | Right ventricular cardiac function as measured by echocardiogram that includes studies for circumferential strain. Measured by percent. | All enrolled subjects with both baseline and 3-month circumferential strain values as assessed by echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of area | baseline, 3 months post-Stage II surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Right Ventricular Cardiac Function Measured by Longitudinal Strain. | Right ventricular cardiac function as measured by echocardiogram that includes studies for longitudinal strain. Measured by percent. | All enrolled subjects with both baseline and 3-month longitudinal strain values as assessed by echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of area | baseline, 3 months post-Stage II surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | All enrolled subjects with both baseline and 12-month fractional area changes values, as assessed by echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of area | baseline, 12 months post-Stage II surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | All enrolled subjects with both baseline and discharge fractional area change values, as assessed by echocardiogram. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of area | baseline pre-op, hospital discharge from Stage II surgery (an average of 1-6 weeks) |
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| Secondary | Cumulative Days of Hospitalization | Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair. | All enrolled subjects. | Posted | Mean | Standard Deviation | days | 1-month post Stage II surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight | Change in weight between baseline and 3-months post Stage II surgery. Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used. | All enrolled subjects with weight values at both baseline and 3-months. | Posted | Mean | Standard Deviation | kg | baseline, 3-months post Stage II surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Heart Rate | Change in heart rate between baseline and 3-months post Stage II surgery. Heart rate as measured at home by subject's caregiver as standard of care per subject's provider. Caregivers will be instructed by the site staff on the best way to perform. | All enrolled subjects with heart rate values at both baseline and 3-months. | Posted | Mean | Standard Deviation | beats per minute | baseline, 3-months post Stage II surgery |
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| Secondary | Change in Oxygen Saturation | Change in oxygen saturation between baseline and 3-months post Stage II surgery. Oxygen saturation as measured at home by subject's caregiver using the pulse oximetry device provided as standard of care by subject's provider. Caregivers will be instructed by the site to use the same pulse oximetry device for every home measurement of oxygen saturation. | All enrolled subjects with oxygen saturation values at both baseline and 3-months. | Posted | Mean | Standard Deviation | percentage of saturation | baseline, 3-months post Stage II surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Weight | Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used. | Enrolled subjects with weight values available at each 6-month follow-up visit. | Posted | Mean | Standard Deviation | kg | baseline, every 6 months post-Stage II surgery |
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| Secondary | Change in Arrhythmia and Heart Failure Medication | Changes in arrhythmia and heart failure medications will be recorded by caregiver on the concomitant medication diary throughout the subject's participation in the study starting at the time of consent. | All enrolled subjects. | Posted | Count of Participants | Participants | 3-months post-surgery |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Stage III Surgical Repair | The number of research subjects eligible for Stage III surgical repair | Not Posted | Feb 2026 | Stage III surgery pre-op, approx. 4 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Time Until Listed for Cardiac Transplantation | The number of days between Stage II surgery and listed on cardiac transplantation list. | Not Posted | Feb 2026 | up to Stage III surgery pre-op, approx. 4 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) | Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent. | Not Posted | Feb 2026 | baseline, Stage III surgery pre-op | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Time Until Death | The number of days between Stage II surgery and death occurrence | Not Posted | Feb 2026 | approx 4 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Days of Hospitalization | Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair. | All enrolled subjects. | Posted | Mean | Standard Deviation | days | 3-months post Stage II surgery |
|
4 years
Specific Adverse Event Terms will not be reported.
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 | Treatment | Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. | 4 | 50 | 38 | 50 | 48 | 50 |
| EG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. | 3 | 45 | 27 | 45 | 45 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other Specify | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac disorders - Other specify | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chylous ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colonic perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Death NOS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other specify | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Edema face | General disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fever | General disorders | MedDRA | Systematic Assessment |
| |
| Flu like symptoms | General disorders | MedDRA | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal disorders - Other specify | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| General disorders - Other specify | General disorders | MedDRA | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Infections and infestations - Other specify | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other specify | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Intraoperative cardiac injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Mediastinal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other specify | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA | Systematic Assessment |
| |
| Muscle weakness left-sided | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nervous system disorders - Other specify | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Recurrent laryngeal nerve palsy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Renal and urinary disorders - Other specify | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other specify | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Spasticity | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Surgical and medical procedures - Other specify | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Tricuspid valve disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound infection | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac disorders - Other, specify | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Paroxysmal atrial tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tricuspid valve disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Congenital, familial and genetic disorders - Other, specify | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Endocrine disorders - Other, specify | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA | Systematic Assessment |
| |
| Periorbital edema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Edema face | General disorders | MedDRA | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Fever | General disorders | MedDRA | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, specify | General disorders | MedDRA | Systematic Assessment |
| |
| Generalized edema | General disorders | MedDRA | Systematic Assessment |
| |
| Localized edema | General disorders | MedDRA | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Portal hypertension | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Immune system disorders - Other, specify | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Bacteremia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis infective | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Thrush | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Injury, poisoning and procedural complications - Other, specify | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Intraoperative hemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Postoperative hemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Thyroid stimulating hormone increased | Investigations | MedDRA | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorder - Other, specify | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Ischemia cerebrovascular | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Psychiatric disorders - Other, specify | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Stridor | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Surgical and medical procedures - Other, specify | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Capillary leak syndrome | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Peripheral ischemia | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Vascular disorders - Other, specify | Vascular disorders | MedDRA | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clint Hagen | Mayo Clinic | (507) 577-1764 | hagen.clint@mayo.edu |
| Nov 26, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D018636 | Hypoplastic Left Heart Syndrome |
| D006330 | Heart Defects, Congenital |
| D000080039 | Univentricular Heart |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
|
|
|
|
|
| OG001 |
| Control |
Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
| OG001 |
| Control |
Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
| OG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
| OG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
|
|
|
| OG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
| OG001 |
| Control |
Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
| OG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
| OG001 | Control | Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle. |
|
|
|
|
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|
| Not Prescribed |
|
| Same |
|