Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves

Completed · Not applicable

Conditions studied: Eisenmenger Syndrome

In brief

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.

Key facts

Study ID

NCT02119442

Run by

University of California, Los Angeles

People needed

90

Starts

2013-08-01

Expected to finish

2018-02-01

Last updated by the study team

2019-04-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• There are no known contraindications for implantation of the Melody Valve or the Edwards Sapien Valve

Where it is running

• University of California Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.