Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects Clinical Trial
Official title:
Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits
| Verified date | October 2019 |
| Source | Medtronic Cardiovascular |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | August 10, 2018 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Landes-Kinderklinik | Linz | |
| Canada | Stollery Childrens Hospital | Edmonton | Alberta |
| Spain | Hospital General Universitario Gregorio Marañón | Madrid | |
| United States | Nationwide Childrens Hospital | Columbus | Ohio |
| United States | Children's Hospital of Michigan | Detroit | Michigan |
| United States | University of California - Los Angeles | Los Angeles | California |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | Seattle Childrens and Regional Hospital | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Heart Valves |
United States, Austria, Canada, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 |
6 Months | |
| 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. |
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: 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. |
2 Years | |
| 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 |
1 Year, 2 Years | |
| 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. |
At Time Of Procedure | |
| 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) |
2 years |