N/A
N=90
Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
Eisenmenger Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02119442 ↗Enrolled (actual)
90
Serious AEs
10.0%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants Who Developed Infective Endocarditis — 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcather Valve Implantation (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Infective Endocarditis |
9 | — |
Summary
A growing body of data, suggests that transcatheter valves are effective when implanted in other locations (mitral, aortic, tricuspid) and in high pressure environments. The investigators plan to offer transcatheter valve implantation as an alternative to high risk surgery in patients who require revision of a stenotic or regurgitant valve in the non-pulmonary position (mitral, aortic, tricuspid). This therapy can provide an alternative to patients who may be considered high risk and may not be able to survive a surgical procedure.The use of the devices on this protocol are for medical treatment and are not part of a clinical trial.
Eligibility Criteria
Inclusion Criteria
- Patients will be considered eligible for transcatheter valve implantation if the risk of serious morbidity or mortality with surgical intervention is deemed to be greater than 10 percent by the treating cardiologist and consulting surgeon. The Melody Valve is intended for use in the following clinical conditions:
- Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, AND
- Dysfunctional RVOT conduits with a clinical indication for intervention, AND EITHER
- Regurgitation ≥ moderate
- Stenosis: mean right ventricular outflow tract gradient ≥ 35 mmHg
- The Edwards Sapien Valve will be used in the aortic position for valves and conduits larger than 23mm in diameter with a landing zone less than 26-27mm, otherwise the melody valve will be considered
- The Edwards Sapien Vavle will also be considered in other positions that have an adequate landing zone and a large enough circumference
- The Melody valve may be utilized outside of its approved indications for valve replacement in high risk surgical patients
Exclusion Criteria
- There are no known contraindications for implantation of the Melody Valve or the Edwards Sapien Valve
Data sourced from ClinicalTrials.gov (NCT02119442). 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.