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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

Many forms of congenital and structural heart disease require surgical placement of prosthetic valves and conduits. These conditions include many common congenital heart abnormalities such as Tetralogy of Fallot, Double Outlet Right Ventricle, Truncus Arteriosus and patients who require the Ross procedure for aortic stenosis. There are a variety of acquired conditions, including calcific aortic valve stenosis that may require surgical or transcatheter valve treatment. Unfortunately, when valved conduits are placed surgically, they ultimately become narrowed or regurgitant and require periodic replacement. Thus, patients with these conditions often undergo multiple open heart surgeries during their lifetime. Although the risk of mortality with this kind of surgery is low, surgical intervention is associated with significantly longer recovery times and more patient discomfort when compared to transcatheter interventions. Over the last decade, techniques have been developed to palliate these forms of congenital and structural heart disease using catheters inserted through blood vessels in the groin. These transcatheter techniques have allowed patients to delay or avoid open heart surgery.

The Medtronic Melody Trancatheter Valve and the Edwards SAPIEN Transcatheter Heart Valve are both bioprosthetic valves mounted within metal stents. Their entire structure is collapsible, allowing it to be inserted through delivery sheaths and threaded into the heart, typically without the need of surgical cardiopulmonary bypass. Some of these procedures may be performed using a hybrid technique of minimal surgical access and transcatheter valve delivery. The valves can then be expanded into place by inflating a balloon (similar to how stents are placed elsewhere in the heart, like the coronary artery). The Melody Valve received a humanitarian device exemption (HDE) from the FDA and the Edwa
Sponsor: University of California, Los Angeles

Current Primary Outcome: Number of participants who require subsequent valve repair [ Time Frame: 10 years ]

The investigator will be assessing the efficacy of transcatheter heart valve (THV) by evaluating survival, adverse events, development of subsequent valve issues, and need for second valve repair.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, Los Angeles

Dates:
Date Received: April 8, 2014
Date Started: August 2013
Date Completion: August 2018
Last Updated: June 3, 2016
Last Verified: June 2016