Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Conditions
Brief summary
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.
Interventions
DEVICEMelody Transcatheter Pulmonary Valve PB1016
Sponsors
Medtronic Heart Valves
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment * Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.
Exclusion criteria
* Implantation in the aortic, tricuspid, or mitral position * Venous anatomy unable to accommodate a 22-Fr size introducer sheath * Obstruction of the central veins * Clinical or biological signs of infection including active endocarditis * History of intravenous substance abuse * Currently participating in an investigational drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months | 6 Months | Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year | 1 Year | Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation. |
| Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years | 2 Years | Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation. |
| Number of Subjects With Serious Procedure-related and Device-related Adverse Events | 1 Year, 2 Years | * Serious procedure-related adverse events at 1year and 2 years post-implant * Serious device-related adverse events at 1 year and 2 years post-implant |
| Number of Subjects With Procedural Success | At Time Of Procedure | A successful implant is defined as follows: * Melody TPV PB1016 is fixated within the desired location * RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is \< 35 mmHg * No more than trace/trivial pulmonary regurgitation by angiography * Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant. |
| Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 | 2 years | * Kaplan-Meier: Freedom from Stent Fracture * Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016 * Kaplan-Meier: Freedom from RVOT Conduit Operation * Kaplan-Meier: Freedom from Death (All-Cause) |
Countries
Austria, Canada, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No implant attempted of study device | 9 |
| Overall Study | No primary outcome data available | 2 |
Baseline characteristics
| Characteristic | Melody PB1016 Subjects Consented (i.e. Enrolled) |
|---|---|
| Age, Continuous | 15.2 years STANDARD_DEVIATION 6.3 |
| Region of Enrollment Austria | 4 participants |
| Region of Enrollment Canada | 3 participants |
| Region of Enrollment Spain | 3 participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 16 / 39 |
| serious Total, serious adverse events | 14 / 39 |
Outcome results
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: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation
Time frame: 6 Months
Population: 28 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 6 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted > 24 Hours Cohort | Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months | 25 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: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation.
Time frame: 1 Year
Population: 25 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 1 year.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted > 24 Hours Cohort | Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year | 23 Participants |
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: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation.
Time frame: 2 Years
Population: 27 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 2 years.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted > 24 Hours Cohort | Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years | 25 Participants |
Secondary
Number of Subjects With Procedural Success
A successful implant is defined as follows: * Melody TPV PB1016 is fixated within the desired location * RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is \< 35 mmHg * No more than trace/trivial pulmonary regurgitation by angiography * Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant.
Time frame: At Time Of Procedure
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted > 24 Hours Cohort | Number of Subjects With Procedural Success | 25 Participants |
Secondary
Number of Subjects With Serious Procedure-related and Device-related Adverse Events
* Serious procedure-related adverse events at 1year and 2 years post-implant * Serious device-related adverse events at 1 year and 2 years post-implant
Time frame: 1 Year, 2 Years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Implanted > 24 Hours Cohort | Number of Subjects With Serious Procedure-related and Device-related Adverse Events | 8 Participants |
| Catheterized Cohort: Procedure-related SAEs at 2 Yrs | Number of Subjects With Serious Procedure-related and Device-related Adverse Events | 8 Participants |
| Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr | Number of Subjects With Serious Procedure-related and Device-related Adverse Events | 1 Participants |
| Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs | Number of Subjects With Serious Procedure-related and Device-related Adverse Events | 3 Participants |
Secondary
Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016
* Kaplan-Meier: Freedom from Stent Fracture * Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016 * Kaplan-Meier: Freedom from RVOT Conduit Operation * Kaplan-Meier: Freedom from Death (All-Cause)
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanted > 24 Hours Cohort | Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 | 96.4 percentage of subjects |
| Catheterized Cohort: Procedure-related SAEs at 2 Yrs | Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 | 96.7 percentage of subjects |
| Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr | Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 | 100 percentage of subjects |
| Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs | Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 | 96.7 percentage of subjects |