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Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melody TPV PB1016 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melody Transcatheter Pulmonary Valve PB1016 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months | Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following:
| 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year | Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - Los Angeles | Los Angeles | California | 90095 | United States | ||
| Children's Hospital of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30419603 | Derived | Morray BH, Jones TK, Coe JY, Gitter R, Martinez JZ, Turner DR, Gray RG, Lung TH, Berman DP, Levi DS. Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):474-480. doi: 10.1002/ccd.27974. Epub 2018 Nov 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Melody PB1016 Subjects Consented (i.e. Enrolled) | This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects consented
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| ID | Title | Description |
|---|---|---|
| BG000 | Melody PB1016 Subjects Consented (i.e. Enrolled) | This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the 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 |
| 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 | Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months | Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following:
| 28 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 6 months. | Posted | Count of Participants | Participants | 6 Months |
|
Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit.
Serious Adverse Event:
led to death,
led to a serious deterioration in the health of the subject, resulting in
led to foetal distress, death or congenital abnormality/birth defect.
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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 | Melody PB1016 Subjects Consented (i.e. Enrolled) | This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Megan Mueller, Clinical Research Manager | Medtronic | 612-916-4771 | megan.d.mueller@medtronic.com |
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| 1 Year |
| Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years | Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following:
| 2 Years |
| Number of Subjects With Serious Procedure-related and Device-related Adverse Events |
| 1 Year, 2 Years |
| Number of Subjects With Procedural Success | A successful implant is defined as follows:
| At Time Of Procedure |
| Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 |
| 2 years |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Nationwide Childrens Hospital | Columbus | Ohio | 43205 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84132 | United States |
| Seattle Childrens and Regional Hospital | Seattle | Washington | 98105 | United States |
| Landes-Kinderklinik | Linz | Austria |
| Stollery Childrens Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year | Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following:
| 25 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 1 year. | Posted | Count of Participants | Participants | 1 Year |
|
|
|
| Secondary | Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years | Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following:
| 27 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 2 years. | Posted | Count of Participants | Participants | 2 Years |
|
|
|
| Secondary | Number of Subjects With Serious Procedure-related and Device-related Adverse Events |
| Posted | Count of Participants | Participants | 1 Year, 2 Years |
|
|
|
| Secondary | Number of Subjects With Procedural Success | A successful implant is defined as follows:
| In one subject, the right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient was not collected, leaving the overall number of evaluable subjects analyzed at 29 versus 30. | Posted | Count of Participants | Participants | At Time Of Procedure |
|
|
|
| Secondary | Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 |
| Posted | Number | percentage of subjects | 2 years |
|
|
|
| 0 |
| 39 |
| 14 |
| 39 |
| 16 |
| 39 |
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Cardiac Disorder | Cardiac disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Junctional Rhythm | Cardiac disorders | Systematic Assessment |
|
| Pulmonary Valve Stenosis | Cardiac disorders | Systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Device Complication | General disorders | Systematic Assessment |
|
| Device Rupture | General disorders | Systematic Assessment |
|
| Endocarditis | Infections and infestations | Systematic Assessment |
|
| Prosthetic Valve Endocarditis | Infections and infestations | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Procedural Hemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Central Nervous System Disorder* | Nervous system disorders | Systematic Assessment |
|
| Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tricuspid Regurgitation | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal Disorder | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Adverse Event | General disorders | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Upper Repiratory Tract Infection | Infections and infestations | Systematic Assessment |
|
| Vascular Access Complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Disorder | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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