N/A
N=131
Melody® Transcatheter Pulmonary Valve Post-Approval Study
Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
Bottom Line
View on ClinicalTrials.gov: NCT01186692 ↗Enrolled (actual)
131
Serious AEs
43.3%
Results posted
Dec 2016
Primary outcome: Primary: Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation — 96.7 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Melody® Transcatheter Pulmonary Valve (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Medtronic Cardiovascular
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation |
96.7 | — |
| SECONDARY Procedural Success |
92.1 | — |
| SECONDARY Serious Procedural Adverse Events |
19.2 | — |
| SECONDARY Serious Device-related Adverse Events |
11.0 | — |
| SECONDARY Changes in NYHA Functional Classification |
93; 51; 39; 3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01186692). 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.