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The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melody TPV Implant | Experimental | Melody Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Pulmonary Valve replacement | Device | Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Freedom From TPV Dysfunction | To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:
| 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From TPV Dysfunction at 10 Years | The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg). | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicklaus Children's Hospital | Miami | Florida | 33155 | United States | ||
| Children's Hospital Boston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34930015 | Derived | Jones TK, McElhinney DB, Vincent JA, Hellenbrand WE, Cheatham JP, Berman DP, Zahn EM, Khan DM, Rhodes JF Jr, Weng S, Bergersen LJ. Long-Term Outcomes After Melody Transcatheter Pulmonary Valve Replacement in the US Investigational Device Exemption Trial. Circ Cardiovasc Interv. 2022 Jan;15(1):e010852. doi: 10.1161/CIRCINTERVENTIONS.121.010852. Epub 2021 Dec 21. | |
| 31419019 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | All subjects enrolled (n=171) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Procedural Success | Procedural success is a composite outcome defined as:
| Within 24 Hours post implant |
| Serious Procedural Adverse Event (AE) | A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system). | 5 years |
| Serious Procedural Adverse Event (AE) | A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system). | 10 years |
| Serious Device-related Adverse Event | A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow). | 5 years |
| Serious Device-related Adverse Event | A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow). | 10 years |
| Kaplan-Meier Freedom From Major Stent Fracture at 5 Years | Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure. | 5 years |
| Kaplan-Meier Freedom From Major Stent Fracture at 10 Years | Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure. | 10 years |
| Kaplan-Meier Freedom From Catheter Re-intervention on TPV | Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV | 5 years |
| Kaplan-Meier Freedom From Catheter Re-intervention on TPV | Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV | 10 years |
| Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit | Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV | 5 years |
| Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit | Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV | 10 years |
| Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) | Deaths is defined as all-cause, procedural and device-related events at 5 years | 5 years |
| Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) | Deaths is defined as all-cause, procedural and device-related events at 10 years | 10 years |
| Functional Assessment (NYHA Classification) | Improvement in Functional Assessment (NYHA Classification) at 6 months post implant. | 6 Months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Children's Hospital of NY-Presbyterian | New York | New York | 10032 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Seattle Children's and Regional Hospital | Seattle | Washington | 98105 | United States |
| Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16. |
| 30682562 | Derived | Priromprintr B, Silka MJ, Rhodes J, Batra AS. A prospective 5-year study of exercise performance following Melody valve implant. Am Heart J. 2019 Mar;209:47-53. doi: 10.1016/j.ahj.2018.12.014. Epub 2018 Dec 29. |
| 27453127 | Derived | Priromprintr B, Silka MJ, Rhodes J, Batra AS. A prospective 5-year study of the frequency of arrhythmias during serial exercise testing and clinical follow-up after Melody valve implant. Heart Rhythm. 2016 Nov;13(11):2135-2141. doi: 10.1016/j.hrthm.2016.07.023. Epub 2016 Jul 21. |
| 25944758 | Derived | Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, McElhinney DB. Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial. Circulation. 2015 Jun 2;131(22):1960-70. doi: 10.1161/CIRCULATIONAHA.114.013588. Epub 2015 May 5. |
| 23735475 | Derived | McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4. |
| 22075927 | Derived | McElhinney DB, Cheatham JP, Jones TK, Lock JE, Vincent JA, Zahn EM, Hellenbrand WE. Stent fracture, valve dysfunction, and right ventricular outflow tract reintervention after transcatheter pulmonary valve implantation: patient-related and procedural risk factors in the US Melody Valve Trial. Circ Cardiovasc Interv. 2011 Dec 1;4(6):602-14. doi: 10.1161/CIRCINTERVENTIONS.111.965616. Epub 2011 Nov 9. |
| 20644013 | Derived | McElhinney DB, Hellenbrand WE, Zahn EM, Jones TK, Cheatham JP, Lock JE, Vincent JA. Short- and medium-term outcomes after transcatheter pulmonary valve placement in the expanded multicenter US melody valve trial. Circulation. 2010 Aug 3;122(5):507-16. doi: 10.1161/CIRCULATIONAHA.109.921692. Epub 2010 Jul 19. |
| COMPLETED |
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| NOT COMPLETED |
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All stubjects enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Cohort | All subjects enrolled |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Kaplan-Meier Freedom From TPV Dysfunction | To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody > PControl. TPV dysfunction is a composite outcome defined as the following:
| The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
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| Secondary | Freedom From TPV Dysfunction at 10 Years | The outcome measure for this objective is TPV dysfunction, which is a composite outcome defined as RVOT reoperation for conduit dysfunction or device-related reasons, catheter re-intervention on the TPV, or hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mmHg). | Posted | Number | 95% Confidence Interval | Percentage of subjects | 10 years |
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| Secondary | Procedural Success | Procedural success is a composite outcome defined as:
| The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened). | Posted | Number | percentage of subjects | Within 24 Hours post implant |
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| Secondary | Serious Procedural Adverse Event (AE) | A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system). | The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV. | Posted | Number | Percent of subjects | 5 years |
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| Secondary | Serious Procedural Adverse Event (AE) | A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system). | The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV. | Posted | Number | percentage of subjects | 10 years |
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| Secondary | Serious Device-related Adverse Event | A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow). | The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted. | Posted | Number | Percentage of subjects | 5 years |
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| Secondary | Serious Device-related Adverse Event | A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow). | The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted. | Posted | Number | percentage of subjects | 10 years |
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| Secondary | Kaplan-Meier Freedom From Major Stent Fracture at 5 Years | Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure. | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
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| Secondary | Kaplan-Meier Freedom From Major Stent Fracture at 10 Years | Major stent fracture is defined as a stent fracture requiring intervention to prevent permanent impairment of a body function or permanent damage to a body structure. | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
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| Secondary | Kaplan-Meier Freedom From Catheter Re-intervention on TPV | Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
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| Secondary | Kaplan-Meier Freedom From Catheter Re-intervention on TPV | Catheter Re-intervention is defined as: any catheter-based intervention involving the TPV, including balloon dilatation, stenting, or placement of a second TPV | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
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| Secondary | Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit | Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
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| Secondary | Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit | Surgical Replacement of the RVOT Conduit is defined as any surgical procedure to repair, alter, or explant the TPV | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
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| Secondary | Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) | Deaths is defined as all-cause, procedural and device-related events at 5 years | Posted | Number | 95% Confidence Interval | percentage of subjects | 5 years |
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| Secondary | Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related) | Deaths is defined as all-cause, procedural and device-related events at 10 years | The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV. | Posted | Number | 95% Confidence Interval | percentage of subjects | 10 years |
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| Secondary | Functional Assessment (NYHA Classification) | Improvement in Functional Assessment (NYHA Classification) at 6 months post implant. | The Implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours and had paired data from pre-implant to 6 months post-implant. | Posted | Count of Participants | Participants | 6 Months |
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Adverse event data were collected from the time of consent through end of participation in the study.
Any undesirable clinical occurrence or untoward deviation in health from the patient's baseline condition at the time of consent. Clinically significant worsening of a baseline condition requiring a new intervention, Deterioration of primary disease, Intercurrent illness, AEs related or possibly related to the implant that are greater in intensity and require different clinical intervention than normally required, and Abnormal findings on diagnostic tests not present at the onset of the study.
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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 | Catheterized Cohort | The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV. | 8 | 167 | 106 | 167 | 112 | 167 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Aortic Regurgitation | Cardiac disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
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| Cardiac Disorder | Cardiac disorders | Systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
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| Complete Heart Block | Cardiac disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Intracardiac Mass | Cardiac disorders | Systematic Assessment |
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| Premature Ventricular Ectopic Beats | Cardiac disorders | Systematic Assessment |
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| Pulmonary Valve Disease | Cardiac disorders | Systematic Assessment |
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| Pulmonary Valve Regurgitation | Cardiac disorders | Systematic Assessment |
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| Pulmonary Valve Stenosis | Cardiac disorders | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Tricuspid Regurgitation | Cardiac disorders | Systematic Assessment |
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| Ventricular Fibrillation | Cardiac disorders | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
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| Other Events | General disorders | Systematic Assessment | For the 23 "other serious" events reported by the sites as "other" event, the only event reported >once was depression (3 subjects). All the rest were unique events. |
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| Chest Pain | General disorders | Systematic Assessment |
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| Device Complication | General disorders | Systematic Assessment |
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| Device Rupture | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Multi Organ Failure | General disorders | Systematic Assessment |
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| Prosthetic Cardiac Valve Malfunction | General disorders | Systematic Assessment |
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| Prosthetic Tissue Defect | General disorders | Systematic Assessment |
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| Stent Strut Fracture | General disorders | Systematic Assessment |
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| Endocarditis | Infections and infestations | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Prosthetic Valve Endocarditis | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| Vascular Access Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Prosthetic Cardiac Valve Thrombosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Central Nervous System Disorder | Nervous system disorders | Systematic Assessment |
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| Cva | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Renal Disorder | Renal and urinary disorders | Systematic Assessment |
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| Renal Insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hemothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary Thromboembolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Embolism | Vascular disorders | Systematic Assessment |
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| Hemorrhage | Vascular disorders | Systematic Assessment |
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| Vascular Dissection | Vascular disorders | Systematic Assessment |
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| Venous Thrombosis | Vascular disorders | Systematic Assessment |
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| Vessel Perforation | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemolysis | Blood and lymphatic system disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Cardiac Disorder | Cardiac disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Tricuspid Regurgitation | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
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| Other Events | General disorders | Systematic Assessment | For the 69 "other" events reported by the sites as "other" event, the only events reported >twice were fatigue (5), depression (4), anxiety (4) and abdominal pain (3) |
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| Chest Pain | General disorders | Systematic Assessment |
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| Stent Strut Fracture | General disorders | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Central Nervous System Disorder | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Renal Disorder | Renal and urinary disorders | Systematic Assessment |
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| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karla Mezera | Medtronic | 612-306-4325 | karla.p.mezera@medtronic.com |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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