Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
Conditions
Brief summary
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.
Interventions
DEVICEMelody® Transcatheter Pulmonary Valve
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.
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted * Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)
Exclusion criteria
* Implantation in the aortic 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 * Unwilling or unable to provide written informed consent or comply with the follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation | 6 months | Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 6 Months | Procedural success is defined as a composite of the following: * The TPV is fixated within the desired location, and * The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and * There is no more than trivial pulmonary regurgitation by angiography * The subject is free from explantation of the TPV at 24 hours post-implant |
| Serious Procedural Adverse Events | 6 Months | 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). |
| Serious Device-related Adverse Events | 6 months | 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). |
| Changes in NYHA Functional Classification | 6 Months | Change in NYHA functional class from pre-implant to 6 month post-implant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Cohort All subjects enrolled. | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Futher testing contraindicated implant | 19 |
| Overall Study | Not Catheterized | 11 |
Baseline characteristics
| Characteristic | Enrolled Cohort |
|---|---|
| Age, Continuous | 20.1 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 131 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 120 |
| serious Total, serious adverse events | 52 / 120 |
Outcome results
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: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanted >24 Hours Cohort | Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation | 96.7 percentage of patients |
Secondary
Changes in NYHA Functional Classification
Change in NYHA functional class from pre-implant to 6 month post-implant
Time frame: 6 Months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implanted >24 Hours Cohort | Changes in NYHA Functional Classification | Changes in NYHA Functional Classification | 93 participants |
| Implanted >24 Hours Cohort | Changes in NYHA Functional Classification | Improved | 51 participants |
| Implanted >24 Hours Cohort | Changes in NYHA Functional Classification | No Change | 39 participants |
| Implanted >24 Hours Cohort | Changes in NYHA Functional Classification | Worsened | 3 participants |
Secondary
Procedural Success
Procedural success is defined as a composite of the following: * The TPV is fixated within the desired location, and * The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and * There is no more than trivial pulmonary regurgitation by angiography * The subject is free from explantation of the TPV at 24 hours post-implant
Time frame: 6 Months
Population: The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanted >24 Hours Cohort | Procedural Success | 92.1 percentage of patients |
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).
Time frame: 6 months
Population: The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanted >24 Hours Cohort | Serious Device-related Adverse Events | 11.0 percentage of patients |
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).
Time frame: 6 Months
Population: The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanted >24 Hours Cohort | Serious Procedural Adverse Events | 19.2 percentage of patients |