Melody PB1016 Surveillance Study
- Conditions
- Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
- Interventions
- Device: Melody Transcatheter Pulmonary Valve PB1016
- Registration Number
- NCT02347189
- Lead Sponsor
- Medtronic Heart Valves
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Melody TPV PB1016 Melody Transcatheter Pulmonary Valve PB1016 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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-implantNumber 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)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.
Trial Locations
- Locations (8)
Landes-Kinderklinik
🇦🇹Linz, Austria
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
Stollery Childrens Hospital
🇨🇦Edmonton, Alberta, Canada
Seattle Childrens and Regional Hospital
🇺🇸Seattle, Washington, United States
Nationwide Childrens Hospital
🇺🇸Columbus, Ohio, United States
Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States