Aortic Valve Replacement Without Major Surgery for Patients With Aortic Stenosis (Narrowing of the Aortic Heart Valve)

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"You are being considered for this research study because you have severe aortic stenosis (narrowing of the aortic valve) without symptoms."
Age: 65 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: AsYmptomatic Severe Aortic Stenosis
Type: Device study
Target:
15 Participants
Investigator:
Description
The purpose for the study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis and do not have symptoms. Severe calcific aortic stenosis is a narrowing of the aortic heart valve. In these cases, calcium has attached to the valve surface, resulting in obstructed blood flow.

You are being considered for this research study because your doctors have determined that you have this condition and do not have symptoms. Patients that participate in this study will be chosen at random to be in one of two groups that are part of the main study:

1) TAVR Group:
Some patients will have a procedure to replace their aortic valve using the Edwards SAPIEN 3 THV study device. This is called ‘TAVR’ – transcatheter aortic valve replacement. This group is part of the main study.

2) Clinical Surveillance Group:
Some patients will not have their aortic valve replaced. This group will receive optimum medical therapy as determined by their study doctor. They will be closely watched to see how they are doing (this is called ‘Clinical Surveillance’). This group is part of the main study.

If randomized to the Clinical Surveillance Group, and symptoms of aortic stenosis develop, patients will be offered TAVR. They may receive either the SAPIEN 3 valve, another commercial valve, or surgical aortic valve replacement (SAVR) as determined by their study doctor.

Registry Group:
If symptoms develop during the treadmill stress test, patients will be followed in a registry. This group is not part of the main study, but is separate and referred to as the ‘Registry.
This study requires

If you are eligible to take part in the main study you will have a fifty-fifty chance of being assigned to one of two groups: either TAVR or Clinical Surveillance. Neither you nor your study doctor may choose which group you will be assigned.

Devices The Edwards SAPIEN 3 THV is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position. The valve has leaflets (made of biological material derived from cows) to direct the flow of blood in your heart.

The Edwards SAPIEN 3 THV and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV.

Study Procedures – TAVR Group

If you are assigned to the TAVR Group, your aortic valve will be replaced with the SAPIEN 3 valve. The procedure will be performed in a cardiac catheterization laboratory or hybrid operating room. The procedure can be performed under local or general anesthesia. The study team will discuss the valve implantation process with you in great detail.

You will return to the hospital for follow-up evaluations at 30 days, and at 1, 2, 3 and 5 years after the implant procedure.

Study Procedures – Clinical Surveillance Group If you are assigned to the Clinical Surveillance Group, you will be evaluated one year after randomization to determine whether your aortic valve needs to be replaced. This will be done again at 2, 3 and 5 years.

Study Procedures – Registry Group After your Treadmill Stress Test, approximately 2-3 tablespoons of blood will be collected for a Biomarker assessment. This is described later in this consent form. As part of the Registry Group, you will receive a phone call at years 1, 2, 3 and 5 to see how you are doing and ask if you have had any treatment to your aortic valve. No other procedures or assessments will be performed.

Who can participate

Inclusion criteria:

  1. Severe aortic stenosis
  2. Patient is asymptomatic
  3. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.

Exclusion criteria:

  1. Patient is symptomatic.
  2. Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
  3. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
  4. Aortic valve is a unicuspid, bicuspid, or is non-calcified.
  5. Severe aortic regurgitation (>3+).
  6. Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be compensated for taking part in this research study.
Resources
Schedule
Study duration and period
If you are in the main study and assigned to the TAVR Group, your participation will be for 5 years. If you are in the main study and assigned to the Clinical Surveillance Group, your participation could range from 5 to 10 years. If you are in the Registry Group, your participation will be for 5 years.
Recruitment period
From April 23, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Kimberley Book
Research Topic
Conditions:
  • Aortic Stenosis
  • Heart Diseases

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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