N/A
Completed N=39
Melody PB1016 Surveillance Study
Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
Source: ClinicalTrials.gov NCT02347189 ↗
Enrolled (actual)
39
Serious AEs
35.9%
Results posted
Nov 2017
Primary outcomePrimary: Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months — 25 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months |
25 | — |
| SECONDARY Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year |
23 | — |
| SECONDARY Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years |
25 | — |
| SECONDARY Number of Subjects With Serious Procedure-related and Device-related Adverse Events |
8; 8; 1; 3 | — |
| SECONDARY Number of Subjects With Procedural Success |
25 | — |
| SECONDARY Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016 |
96.4; 96.7; 100; 96.7 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02347189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.