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The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melody TPV Implant | Experimental | Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melody® Transcatheter Pulmonary Valve | Device | Transcatheter Pulmonary Valve replacement 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 |
|---|---|---|
| Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation | Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:
The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Procedural success is defined as a composite of the following:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaqueline Kreutzer, MD | Children's Hospital of University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rady Children's Hospital | San Diego | California | 92123 | United States | ||
| Advocate Hope Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31419019 | Derived | 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. | |
| 25459038 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled | All subjects enrolled (n=131) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 Months |
| Serious Procedural Adverse Events | 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). | 6 Months |
| Serious Device-related Adverse Events | 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). | 6 months |
| Changes in NYHA Functional Classification | Change in NYHA functional class from pre-implant to 6 month post-implant | 6 Months |
| Oak Lawn |
| Illinois |
| 60453 |
| United States |
| CS Mott Children's Hospital, University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15201 | United States |
| Children's Medical Center Dallas, UT Southwestern | Dallas | Texas | 75235 | United States |
| Primary Children's Medical Center, University of Utah | Salt Lake City | Utah | 84113 | United States |
| Derived |
| Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17. |
| 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Cohort | All subjects enrolled. |
| 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 | Median | 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 | Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation | Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following:
The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation. | The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of patients | 6 months |
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| Secondary | Procedural Success | Procedural success is defined as a composite of the following:
| 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 patients | 6 Months |
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| Secondary | Serious Procedural Adverse Events | 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 patients | 6 Months |
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| Secondary | Serious Device-related Adverse Events | 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 patients | 6 months |
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| Secondary | Changes in NYHA Functional Classification | Change in NYHA functional class from pre-implant to 6 month 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. Of this population those with evaluable paired NYHA data were included in the analysis. | Posted | Number | participants | 6 Months |
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6 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 | Catheterized Cohort | The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV. | 52 | 120 | 31 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemias NEC | Blood and lymphatic system disorders | Systematic Assessment |
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| Haematological disorders | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiac disorders NEC | Cardiac disorders | Systematic Assessment |
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| Coronary artery disorders NEC | Cardiac disorders | Systematic Assessment |
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| Pulmonary valvular disorders | Cardiac disorders | Systematic Assessment |
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| Rate and rhythm disorders NEC | Cardiac disorders | Systematic Assessment |
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| Supraventricular arrhythmias | Cardiac disorders | Systematic Assessment |
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| Ventricular arrhythmias and cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Gastrointestinal disorders NEC | Gastrointestinal disorders | Systematic Assessment |
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| Nausea and vomiting symptoms | Gastrointestinal disorders | Systematic Assessment |
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| diarrhoea (excl infective) | Gastrointestinal disorders | Systematic Assessment |
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| Device issues NEC | General disorders | Systematic Assessment |
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| Device physical property and chemical issues | General disorders | Systematic Assessment |
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| Febrile disorders | General disorders | Systematic Assessment |
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| Therapeutic and nontherapeutic responses | General disorders | Systematic Assessment |
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| Cardiac infections | Infections and infestations | Systematic Assessment |
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| Lower respiratory tract and lung infections | Infections and infestations | Systematic Assessment |
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| Sepsis, bacteraemia, viraemia and fungaemia NEC | Infections and infestations | Systematic Assessment |
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| Cardiac and vascular procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Non-site specific procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nervous system disorders NEC | Nervous system disorders | Systematic Assessment |
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| Neurological signs and symptoms NEC | Nervous system disorders | Systematic Assessment |
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| Pneumothorax and pleural effusions NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary thrombotic and embolic conditions | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory tract disorders NEC | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Non-site specific embolism and thrombosis | Vascular disorders | Systematic Assessment |
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| Vascular injuries NEC | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain and discomfort NEC | General disorders | Systematic Assessment |
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| Therapeutic and nontherapeutic responses | General disorders | Systematic Assessment |
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| Infections NEC | Infections and infestations | Systematic Assessment |
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| Non-site specific procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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A publication committee is in place for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Patterson | Medtronic | 763.526.1544 | susan.patterson@medtronic.com |
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