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The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Muscular VSD Occluder | Experimental | Implantation with the device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) | Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness End Point: Technical Success | Technical success was defined as successful deployment of the device (Amplatzerâ„¢ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD). | During the procedure |
| Primary Effectiveness End Point: Acute Procedure Success | Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites. | At the end of the procedure |
| Primary Effectiveness End Point: Shunt Closure Success | Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board). | 1-year follow-up visit |
| Primary Safety Endpoint | The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure. | Within 12 months of the procedure |
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Inclusion Criteria:
complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:
Subject/legally authorized representative has signed the informed consent
Subject/legally authorized representative is willing to complete the follow-up requirements of this study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| Phoenix Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42083863 | Derived | Qureshi AM, Justino H, Owada C, Numan M, Ebeid M, Forbes TJ, Nykanen D, Kobayashi D, Kolles J, Gutfinger D, Balzer D. Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular VSD Occluder. Circ Cardiovasc Interv. 2026 Jun;19(6):e016121. doi: 10.1161/CIRCINTERVENTIONS.125.016121. Epub 2026 May 5. |
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Subject enrollment began on 14 May 2008 and concluded on 24 February 2020. A total of 92 subjects were enrolled at 28 investigational sites in the United States and Canada. The post-approval requirements included subject follow-up through 5-years post-procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Muscular VSD Occluder | Implantation with the device Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2020 | Dec 23, 2024 |
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| Phoenix |
| Arizona |
| 85016 |
| United States |
| Children's Hospital Los Angeles (USC) | Los Angeles | California | 90027 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Valley Children's Hospital | Madera | California | 93638 | United States |
| Stanford University Medical Center | Palo Alto | California | 94304 | United States |
| Rady Children's Hospital | San Diego | California | 92123 | United States |
| Children's Hospital of Colorado | Aurora | Colorado | 80045 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510-3202 | United States |
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Arnold Palmer Hospital | Orlando | Florida | 32806 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Sparrow Clinical Research Institute | Lansing | Michigan | 48912 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| University of Missouri-Kansas City School of Medicine | Kansas City | Missouri | 64108 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Sunrise Hospital | Las Vegas | Nevada | 89109 | United States |
| Deborah Heart & Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Children's Hospital of New York-Presbyterian | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Methodist LeBonheur Healthcare | Memphis | Tennessee | 38104 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| BC Children's Hospital | Vancouver | Bristish Columbia | V6H3N1 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Hopital Sainte-Justine | Montreal | Quebec | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Analysis included prospectively (n=80) and retrospectively (n=12) enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Muscular VSD Occluder | Implantation with the device Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device |
| 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 |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Ventricular septal defects (VSD) type | Count of Participants | 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 | Primary Effectiveness End Point: Technical Success | Technical success was defined as successful deployment of the device (Amplatzerâ„¢ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD). | The analysis population included all prospectively enrolled subjects only (N=80) who have an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device), as retrospectively enrolled subjects were selected based on established Technical Success. | Posted | Count of Participants | Participants | During the procedure |
|
|
| ||||||||||||||||||||||||||
| Primary | Primary Effectiveness End Point: Acute Procedure Success | Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites. | The analysis population included all subjects who had an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device). | Posted | Count of Participants | Participants | At the end of the procedure |
|
| |||||||||||||||||||||||||||
| Primary | Primary Effectiveness End Point: Shunt Closure Success | Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board). | The analysis of the shunt closure success included all enrolled subjects who had an attempted device placement (defined as the delivery system enters the subject's body in an attempt to place a device) and a 1-year follow-up visit. | Posted | Count of Participants | Participants | 1-year follow-up visit |
|
| |||||||||||||||||||||||||||
| Primary | Primary Safety Endpoint | The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure. | The Primary Safety endpoint included all enrolled subjects except for withdrawn subjects with no adverse events within the first 12 months and consented screen failures. | Posted | Count of Participants | Participants | Within 12 months of the procedure |
|
|
12 months
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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 | Muscular VSD Occluder | Implantation with the device Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder): Device | 2 | 92 | 51 | 92 | 17 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Lab Value | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Acute Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Arterial Pulse Loss | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Asystole | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Bacteremia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Blood Loss | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Brain Tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | Systematic Assessment |
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| Bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Cerebral Aneurysm | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Chronic Erosive Gastritis | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Common Cold/Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Compartment Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Constipation | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Cyanosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Dehydration | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Device Closure of ASD | Product Issues | MedDRA (11.0) | Systematic Assessment |
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| Device Embolization | Product Issues | MedDRA (11.0) | Systematic Assessment |
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| Device Malposition or Malfunction | Product Issues | MedDRA (11.0) | Systematic Assessment |
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| Diarrhea | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| EKG Abnormalities | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Echo Finding | Investigations | MedDRA (11.0) | Systematic Assessment |
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| Elective Cardiac Surgery | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Elective Procedure | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Elective Surgery | Surgical and medical procedures | MedDRA (11.0) | Systematic Assessment |
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| Emesis/Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Failure to Thrive | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Febrile Seizures | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Fever | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
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| Gastrointestinal Bleeding | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Headache | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Heart Failure | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Hematemesis | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Hemorrhage | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypocalcemia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Hypotension | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Intracerebral Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Intraventricular Haemorrhage | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Ischemic Stroke | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
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| Junctional Escape Rhythm/Intermittent Junctional Rhythm | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Mitral Valve Regurgitation/Mitral Insufficiency | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| PA Band Removal | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Partial Obstruction of the Aorta with a Gradient > 10mm Hg | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Poor Nutrition | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pulmonary Regurgitation/Pulmonary Insufficiency/Valvular Regurgitation: Pulmonary Valve | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Pulmonary Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Residual Shunt | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Respiratory Illness | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Respiratory Syncytial Virus Infection (RSV) | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Right Ventricular Outflow Tract (RVOT) Obstruction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Seizure/Convulsions/Epilepsy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Septicemia | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Stroke | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Systolic Dysfunction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Tachypnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Third Degree Heart Block (Complete Heart Block) | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Thrombus | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Urinary Tract Infections | Renal and urinary disorders | MedDRA (11.0) | Systematic Assessment |
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| Viral Syndrome | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Wound Dehiscence | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Other | General disorders | MedDRA (11.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arterial Hypertension/Hypertension | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Cardiomegaly | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Chest Pain | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Device Malposition or Malfunction | Product Issues | MedDRA (11.0) | Systematic Assessment |
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| Diabetes Mellitus | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Diastolic Dysfunction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Elective Procedure | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
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| Fever | General disorders | MedDRA (11.0) | Systematic Assessment |
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| High Grade Block/Advanced AV Block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Mobitz II Block | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Pericardial Effusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Peripheral Arterial Occlusion | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Poor Nutrition | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
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| Pulmonary Vein Stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Seizure/Convulsions/Epilepsy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
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| Tricuspid Regurgitation/Tricuspid Insufficiency/Valvular Regurgitation: Tricuspid Valve | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Palmer, Director of Clinical Programs | Abbott Structural Heart | +1 651-202-8362 | ryan.palmer@abbott.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2016 | Dec 23, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006345 | Heart Septal Defects, Ventricular |
| ID | Term |
|---|---|
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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