Partner II Trial
Clinical Trial for PARTNER II: Placement of AoRTic TraNscathetER Valves
Aortic valve stenosis, or narrowing of the aortic valve, is a common problem that reduces the ability of the heart to deliver blood to the rest of the body. The traditional treatment for this disease is to perform open heart surgery and replace the diseased valve, which is effective for many patients, but is not always an option for older patients or those with other medical complications. These patients may be referred to as inoperable.
The University of Maryland Heart Center is one of a few centers in the country participating in a clinical trial, known as PARTNER II, that provides a non-surgical approach for treating aortic stenosis using a catheter to deliver the new artificial valve while the heart continues to beat. Patients enrolled in this trial will receive one of two possible valve types through a catheter-based approach in the groin known as transcatheter aortic valve replacement (TAVR).
PARTNER II Trial Overview
This trial will evaluate the safety and effectiveness of the study device called the Edwards SAPIEN XT tissue valve for patients with severe aortic stenosis who are too high-risk to undergo traditional open heart valve surgery. The Edwards SAPIEN XT tissue valve is currently not approved for sale in the US.
The trial will assess the benefit of percutaneous transcatheter aortic valve replacement (TAVR), which is a minimally invasive procedure, in patients with severe aortic stenosis, or narrowing of the aortic valve, who are too high-risk to undergo traditional open heart surgery. All patients enrolled into the PARTNER II trial will undergo TAVR and receive a new valve.
Previous studies from the PARTNER I trial demonstrated lower mortality rates for patients who underwent TAVR versus traditional open heart surgery for the replacement of aortic valves.
Results from The PARTNER II Trial will offer additional insight into how TAVR impacts survival and how the lower profile Edwards SAPIEN XT valve may impact complication rates in very high-risk patients.
The leaflets of a stenotic or calcified aortic heart valve are unable to open wide, obstructing blood flow from the left ventricle into the aorta. The narrowed valve allows less oxygenated blood to flow through and as a result, less oxygen-rich blood is pumped out to the body which may cause symptoms like severe shortness of breath.
*Courtesy of Edwards Lifesciences.
The leaflets of a healthy aortic heart valve open wide to allow oxygenated blood to flow unobstructed through the valve into the aorta where it flows out to the rest of the body.
*Courtesy of Edwards Lifesciences.
How does the procedure work?
The TAVR procedure replaces a patient's diseased “native” valve without traditional open-heart surgery and while the heart continues to beat.
The Edwards SAPIEN XT valve is a collapsible valve that is placed within the aortic valve through a procedure called transcatheter aortic valve implantation. In this procedure the physician threads a long tube (catheter) with a balloon and a heart valve attached to it through a blood vessel in your leg. The heart valve is made of animal tissue. Once the catheter is correctly placed inside the aortic valve, the balloon is inflated, and the valve is released from the tube and anchored into place. The long tube or catheter is then removed.
What types of patients could be eligible to participate?
Patients with aortic stenosis, a narrowed opening in the aortic heart valve, may be eligible to participate in this study. Eligible patients may have been told they are at high-risk for traditional open heart valve surgery. Symptoms of aortic stenosis may include shortness of breath, chest pain, or tiredness and fatigue, which are reducing their quality of life.
Initial evaluation time will vary, but patients should plan on spending at least four hours for the first initial evaluation in the Heart Valve clinic. Patients will receive an echocardiogram and will be evaluated by a cardiologist, a cardiac surgeon and the research team. Additional testing may also be requested from the clinical team during that initial evaluation.
Following the initial evaluation, patients will be required to return to the clinic for a follow-up visit for additional research procedures that are required at specific times prior to the procedure date.
The length of hospital stay following the procedure will vary depending on each patient's condition. Average length of stay is approximately seven days and tends to be shorter than the average stay for open heart surgery.
Patients will be required to attend follow-up appointments in the Heart Valve clinic at 30 days, six months, and one year after the procedure, and then on a yearly basis for up to five years. The follow-up testing will take approximately an hour and a half per visit and is a crucial part of the research protocol.
Who to contact for more information
Contact UMMC's Heart Valve Program at 410-32-VALVE (410-328-2583), or Amy Krebs-Dunnigan at firstname.lastname@example.org.
This page was last updated: April 22, 2013