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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium; often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial, and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients, and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone-marrow derived mesenchymal stem cells (MSCs) have also been studies clinically.
Currently, bone marrow or bone marrow-derived cells represent highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials.
Chronic ischemic left ventricular dysfunction resulting from heart disease is a common and problematic condition; definitive therapy in the form of heart transplantation is available to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for acute MI, but represents a potentially important alternative for this disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive an injection of 100 million or 200 million autologous human mesenchymal stem cells (hMSCs). |
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| 2 | Experimental | Participants will receive an injection of 100 million or 200 million autologous human bone marrow cells (hBMCs). |
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| 3 | Placebo Comparator | Participants will receive a placebo injection of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous human mesenchymal cells (hMSCs) | Biological | Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hMSCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | one month post-catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Measured every 12 hours for the first 48 hours post-catheterization | |
| Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Measured every 12 hours for the first 48 hours post-catheterization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Hare, MD | University of Miami | Principal Investigator |
| Richard P Schwarz, PhD | CV Ventures | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24247587 | Result | Heldman AW, DiFede DL, Fishman JE, Zambrano JP, Trachtenberg BH, Karantalis V, Mushtaq M, Williams AR, Suncion VY, McNiece IK, Ghersin E, Soto V, Lopera G, Miki R, Willens H, Hendel R, Mitrani R, Pattany P, Feigenbaum G, Oskouei B, Byrnes J, Lowery MH, Sierra J, Pujol MV, Delgado C, Gonzalez PJ, Rodriguez JE, Bagno LL, Rouy D, Altman P, Foo CW, da Silva J, Anderson E, Schwarz R, Mendizabal A, Hare JM. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA. 2014 Jan 1;311(1):62-73. doi: 10.1001/jama.2013.282909. | |
| 30005555 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Autologous human bone marrow cells (hBMCs) | Biological | Participants will receive 40 million cells/mL delivered in either a dose of 0.25 mL per injection for a total of 1 x 108 (100 million) hBMCs x 10 injections or a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
|
| Placebo | Biological | Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
|
| Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | 12 months post-catheterization |
| Ectopic Tissue Formation. | 12 months post-catheterization |
| Number of Deaths | 12-months post-catheterization |
| Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test). | Data provided are with respect to the change from baseline at 12-months post-catheterization. | 12 months post-catheterization |
| Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score. | Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life. | 12 months post-catheterization |
| Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT. | Data provided are with respect to the change from baseline at 12-months post-catheterization. | 12 Months post-catheterization |
| Derived |
| Tompkins BA, Rieger AC, Florea V, Banerjee MN, Natsumeda M, Nigh ED, Landin AM, Rodriguez GM, Hatzistergos KE, Schulman IH, Hare JM. Comparison of Mesenchymal Stem Cell Efficacy in Ischemic Versus Nonischemic Dilated Cardiomyopathy. J Am Heart Assoc. 2018 Jul 12;7(14):e008460. doi: 10.1161/JAHA.117.008460. |
| 21392602 | Derived | Trachtenberg B, Velazquez DL, Williams AR, McNiece I, Fishman J, Nguyen K, Rouy D, Altman P, Schwarz R, Mendizabal A, Oskouei B, Byrnes J, Soto V, Tracy M, Zambrano JP, Heldman AW, Hare JM. Rationale and design of the Transendocardial Injection of Autologous Human Cells (bone marrow or mesenchymal) in Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction (TAC-HFT) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy. Am Heart J. 2011 Mar;161(3):487-93. doi: 10.1016/j.ahj.2010.11.024. |
| FG001 | 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| FG002 | Participants Will Receive a Placebo Injection of Phosphate-buf | Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| COMPLETED |
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| NOT COMPLETED |
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This is the number of patients who were randomized and received the study product injection.
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| ID | Title | Description |
|---|---|---|
| BG000 | 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| BG001 | 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| BG002 | Participants Will Receive a Placebo Injection of Phosphate-buf | Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Qualifying ejection fraction, % | Mean | Standard Deviation | percent |
| |||||||||||||||
| History of Coronary Interventions | Number | participants |
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| History of Atrial/Ventricular Arrhythmia | Number | participants |
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| History of Hyptertension | Number | participants |
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| History of Diabetes | Number | participants |
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| History of Congestive Heart Failure | Number | participants |
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| History of Smoking | Number | participants |
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| New York Heart Association Class | New York Heart Association Funcational classificaiton classifies the extent of heart failure in a patient. The 4 categories are based on how much patients are limited by physical activity, breathing, shortness of breath and/or angina pain. A class of 1 is a better New York Heart Association Class and a class of 4 is a worse New York Heart Association Class. | Number | participants |
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| Distance Walked in 6-Minutes | Mean | Standard Deviation | meters |
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| Peak VO2 | Mean | Standard Deviation | mL/kg/min |
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| Predicted FEV1 | Mean | Standard Deviation | percent |
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| Device | Type of cardiac device participant had at baseline. | Number | participants |
| |||||||||||||||
| Imaging Modality | Type of cardiac imaging modality specified for the participant at baseline. | 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 | Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation | Posted | Number | participants | one month post-catheterization |
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| Secondary | Serial Troponin Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Posted | Mean | 95% Confidence Interval | ng/mL | Measured every 12 hours for the first 48 hours post-catheterization |
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| Secondary | Serial Creatine Kinase Values (Every 12 Hours for the First 48 Hours Post-catheterization). | Posted | Mean | 95% Confidence Interval | ng/mL | Measured every 12 hours for the first 48 hours post-catheterization |
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| Secondary | Incidence of the Major Adverse Cardiac Events (MACE) Endpoint, Defined as the Composite Incidence of (1) Death, (2) Hospitalization for Heart Failure, or (3) Non-fatal Recurrent MI. | Posted | Number | participants | 12 months post-catheterization |
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| Secondary | Ectopic Tissue Formation. | Posted | Number | participants | 12 months post-catheterization |
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| Secondary | Number of Deaths | Posted | Number | participants | 12-months post-catheterization |
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| Secondary | Change From Baseline in Distance Walked in Six-minutes (Six-minute Walk Test). | Data provided are with respect to the change from baseline at 12-months post-catheterization. | Posted | Mean | 95% Confidence Interval | meters | 12 months post-catheterization |
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| Secondary | Change From Baseline in the Minnesota Living With Heart Failure (MLHF) Questionnaire Total Score. | Data provided are with respect to the change from baseline at 12-months post-catheterization. The Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months post-catheterization |
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| Secondary | Percent Change From Baseline in Scar Mass as a Fraction of Left Ventricle Mass by Cardiac MRI or CT. | Data provided are with respect to the change from baseline at 12-months post-catheterization. | Posted | Mean | 95% Confidence Interval | percent change | 12 Months post-catheterization |
|
30-days after transendocardial stem cell injection
Adverse events are described by MedDRA preferred term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 200 Million Autologous Human Mesenchymal Stem Cells (hMSCs) | Autologous human mesenchymal cells (hMSCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 2 | 19 | 6 | 19 | ||
| EG001 | 200 Million Autologous Human Bone Marrow Cells (hBMCs) | Autologous human bone marrow cells (hBMCs): Participants will receive 40 million cells/mL delivered in a dose of 0.5 mL per injection for a total of 2 x 108 (200 million) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 2 | 19 | 7 | 19 | ||
| EG002 | Participants Will Receive a Placebo Injection of Phosphate-buf | Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. | 3 | 21 | 5 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Intracardiac thrombus | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Device electrical finding | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Device malfunction | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Fibrosis | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Dyspnoea exertional | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
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| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Intracardiac thrombus | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Eye inflammation | Eye disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Food Poisoning | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Device occlusion | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
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| Investigations | Investigations | MedDRA 10.0 | Non-systematic Assessment |
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| Injury, Poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Renal failure chronic | Renal and urinary disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Epididymitis | Reproductive system and breast disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Surgical and Medical procedures | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment | - Stent placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Mendizabal, Biostatistician | The EMMES Corporation | 301-251-1161 | 221 | amendizabal@emmes.com |
| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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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| No |
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| No |
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| No |
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| No |
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| No |
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| No |
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| II |
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| III |
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| Unknown |
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| Biventricular Pacing |
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| None |
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| CT |
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| Title | Measurements |
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| Units | Counts |
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| Units | Counts |
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| Participants |
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| OG002 |
| Participants Will Receive a Placebo Injection of Phosphate-buf |
Placebo: Participants will receive 0.5 mL injections of phosphate-buffered saline (PBS) and 1% human serum albumin (HAS) x 10 injections. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter. |
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