Transcatheter Valve Implantation in Patients With Dysfunctional Left and Right Sided Heart Valves
Phase: NA
Conditions: Eisenmenger Syndrome
Sponsor: University of California, Los Angeles

Transcatheter Valve Implantation in Patients With Dysfunctional Left and 
Right Sided Heart Valves 
 
 
 
NCT02119442 
 
August 15, 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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 
greater 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 Transcatheter 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 threated 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 Edwards SAPIEN Valve has market approval from the FDA for 
implantation in the aortic position. The investigators plan to offer these transcatheter valves as 
alternatives to eligible patients who require replacement of a stenotic or regurgitant valve in all 
left and right sided positions.  
The Melody Valve and Edwards SAPIEN Valve are presently being utilized at multiple United 
States centers for valve replacement in all positions (pulmonary, aortic, tricuspid, and mitral) in 
patients who are considered high-risk candidates for surgical valve replacement. The use of the 
devices on this protocol are for medical treatment and are not part of a clinical trial.  
 
OBJECTIVES 
The risks of cardiac surgery include bleeding, stroke, renal failure, and death among other 
potential complications. The use of cardiopulmonary bypass allows surgeons to operate on the 
non-beating heart; however, cardiopulmonary bypass is associated with acute potential 
complications as well as long-term sequelae such as neurologic damage, decreased cognitive 

capacity, and heart damage. Furthermore, the pain associated with cardiac surgery is significant 
and recovery times range from weeks to months. The goal is to improve the quality of patient 
long-term survival by lifetime patient management. To this end, the transcatheter deployment of 
the Melody and SAPIEN devices aim to reduce the number of surgeries required over a lifetime 
by this patient population. 
The intended role of the Melody Transcatheter Valve is to restore pulmonary valve function in 
patients with a dysfunctional right ventricular outflow tract (RVOT) conduit and a clinical 
indication for pulmonary valve replacement. Unlike currently available options for pulmonary 
valve replacement, the transcatheter pulmonary valve (TPV) is intended to be placed with a 
transcatheter delivery system, and thus does not require surgical incisions, open-heart surgery, or 
cardiopulmonary bypass. The ultimate goals and durability of the TPV may differ among 
patients with different indications. At a minimum, the intention is that the TPV will improve the 
hemodynamic function of the existing conduit, mitigate the adverse impact of pulmonary 
regurgitation and/or RVOT obstruction, and effectively extend the longevity of the existing 
conduit and defer the need for conduit replacement. In some patients, delaying surgical conduit 
re-intervention may reduce the number of open-heart surgeries required over the course of their 
lifetime, thereby decreasing the cumulative morbidity and risk associated with such operations. 
Use of the Melody valve and the Edwards SAPIEN Valve outside of their approved indications 
for valve replacement have been published but the data is limited. The available reports suggest 
that both the Melody Valve and the Edwards SAPIEN Valve are efficacious and can be safely 
deployed in the positions outside of their intended use. We intend on offering this intervention to 
patients that are deemed to be high-risk for traditional surgical valve replacement. 
 
DESIGN & METHODS 
Patients and/or their legal guardians will be consented for implantation of the TPV prior to the 
procedure by the implanting physician(s). Transcatheter valves are typically implanted in the 
cardiac catheterization laboratory under general anesthesia. Patients will recover in the post-
anesthesia care unit (PACU) and will be admitted to the hospital for observation following the 
procedure. Patients may be offered treatment with a transcatheter valve replacement when there 
is no other reasonable option (when they are deemed at a high risk for adverse events by a 
consulting cardiac surgeon). 
Prior to implantation, financial authorization will be obtained from patients’ medical insurance 
providers. Patients will be informed that they and/or their medical insurance provider will be 
responsible for the cost of the procedure. Patients will also be informed of the estimated costs 
associated with implantation of a transcatheter valve. They will be given the opportunity to 
discuss these costs with the implanting physician and/or UCLA Patient Business Services prior 

to the procedure. Patients will be advised to check with their insurance to see if it will cover the 
costs of the device implantation, and removal if deemed unsuccessful. 
The Edwrads SAPIEN Valve will be preferred over the Melody Valve when the annulus or 
circumference of the landing zone is greater than 23 mm in diameter. For valve replacements in 
regions smaller than 23 mm in diameter, The Melody Valve will be used.