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NP Patient Abstract

STUDY TITLE: NEUROPROTECTION IN PATIENTS UNDERGOING AORTIC VALVE REPLACEMENT

Current Status: Enrollment Complete

What is the purpose of this research?
All patients undergoing cardiac surgery, including AVR, face a risk for injury to the brain including stroke. Debris, such as plaque, may be dislodged from the wall of the aorta (the large blood vessel leading from the heart to the brain and the rest of the body) during the surgery. It can travel to the brain or other organs (such as the kidneys) and cause injury. The Food and Drug Administration (FDA) has cleared two devices for use during cardiac surgery to capture this debris. These devices include the CardioGard Cannula and the Edwards Embol-X. The researchers in this study are seeking to learn how well these devices reduce the risk of stroke or other injury to the brain.

Who can be in this study?
Patients aged 65 years or older scheduled for surgery for an aortic valve replacement (AVR) may participate in this study. There will be a total of 495 to 535 participants enrolled in this study in a number of medical centers (up to 25) across the United States and Canada.

Who cannot be in this study?
Some reasons a person may not be able to participate in this research study include a history of stroke within three months of surgery and an inability to undergo MRI (for example, a patient with metal implanted in the body would not be able to participate).

What procedures will be followed?
Screening and Pre-Surgical Testing
Participants in the study will have a physical exam and a number of additional tests before the planned surgery to (1) determine whether they are eligible to participate in this study, and (2) to record their pre-surgery or baseline lab results that will be repeated periodically to determine progress after surgery. These tests will include neurocognitive evaluations (tests of thinking and understanding). The neurocognitive tests will take about 45 minutes and will be audiotaped. Participants will also be asked to complete quality of life questionnaires, which will include questions about their mood. In addition, the study team will perform an assessment to look for evidence of a stroke or any other neurological issues.

Prior to the scheduled AVR surgery, participants may undergo a cardiac catheterization. This will involve a cardiologist placing a flexible tube, called a catheter, into one of the blood vessels from which dye is injected that will make images of the heart and blood vessels visible with an x-ray machine. Participants' doctors will need to make the decision as to whether they should have this procedure regardless of whether they participate in this study. While cardiac catheterization is not a procedure that participants will need to undergo to enter the study, if a doctor does decide to have a patient undergo this procedure, the study researchers will record the data that is collected.

In addition to the routine blood tests done prior to surgery, more blood might be taken from participants after surgery to evaluate their health if they begin to feel sick. These additional blood tests are commonly required to evaluate patients' health even if they do not participate in this study. The results of these blood tests will also be collected in this study.

Treatment Assignment
During the AVR surgery, participants will be assigned, by chance (like pulling a number from a hat), to one of three treatment groups:
•  AVR surgery with neither device (standard treatment)
•  AVR surgery with the Edwards Embol-X device
•  AVR surgery with the CardioGard Cannula

Participants will not know their treatment assignment until after their AVR surgery. There may be a need to recruit up to 40 additional participants into the standard therapy group, who are undergoing surgery without one of the devices being tested here. This will allow the researchers to compare each device to the standard therapy group better. This would mean that the chance of being assigned to the group with neither device (standard therapy group) will increase slightly. The chances of being assigned to any one of these three treatment groups are approximately one in three (somewhere between 31% to 38%).

Surgery
In participants assigned to AVR surgery with the Edwards Embol-X embolic protection device, the surgeon will insert the filter into the aorta at the beginning of the surgical procedure and then proceed with replacing the aortic valve. A new filter will be placed in the aorta after 60 minutes or toward the end of the procedure, whichever comes first. Having the filter in place will help to capture the debris that may become dislodged during surgery. The filters will be sent for inspection by a laboratory, where the amount of debris that is captured will be recorded.

In participants assigned to AVR surgery with the CardioGard Cannula, the surgical team will insert the Cardiogard Cannula into the ascending aorta in the chest at the beginning of the procedure. The cannula will suction debris filled blood away from the surgical area and back to the heart-lung bypass machine for filtration through a suction tube. The filter will be sent for inspection by a laboratory, where the amount of debris that is captured will be recorded.

All participants in the trial will have aortic scans using an ultrasound device, to produce images of the aorta, at two times during the surgery. The first will be done before surgery to see the condition of the inner lining of the aorta. The second time will be after surgery to see whether there have been changes to the lining of the aorta related to the surgery.

Monitoring after Surgery
All participants will be monitored for 90 days after surgery. On days 1 and 3 after surgery, participants will undergo an assessment for evidence of a stroke or any other neurological changes.

One week after surgery, participants will undergo diffusion-weighted magnetic resonance imaging (DWI MRI). This is a type of MRI scan that is used to detect strokes. This test will take approximately 60 minutes to complete. Participants will be asked to lie on an MRI table inside a tube and then to stay as still as possible while the MRI machine creates images of the brain using a magnetic field and radio waves. Participants will not feel any pain but will be exposed to loud noises while the machine operates.

The study team will also make note of participants' medications and again assess for stroke or any other neurological changes at one week and one month after surgery.

Ninety days after surgery, participants will again be asked to complete neurocognitive tests (tests of thinking and understanding). The neurocognitive tests will take about 45 minutes and will be audiotaped. Participants will also be asked to complete quality of life questionnaires including questions about mood. The study team will also collect information on medications and will again assess for stroke or any other neurological issues.

What are the possible risks of being in this study?

AVR Surgery Risks
The surgeon will discuss all risks with each participant prior to the surgery. All patients who undergo AVR surgery are at risk for these events whether or not they participate in the research.

Risks for any anesthesia are:
•  Blood clots in the legs that may travel to the lungs
•  Blood loss
•  Breathing problems
•  Infection, including in the lungs, kidneys, bladder, chest, or heart valves
•  Reactions to medicines (allergic reaction, nausea, vomiting)

Risks of any surgery:
•  Pain and discomfort
•  Bruising and swelling
•  Death
•  Difficulty breathing
•  Incision infection
•  Blood infection

Possible additional risks from having aortic valve surgery are:
•  Heart attack or heart failure
•  Stroke
•  Heart rhythm problems
•  Infection of the new valve
•  Kidney problems or failure
•  Memory loss and loss of mental clarity, or "fuzzy thinking"
•  Poor healing of the incision
•  Low-grade fever
•  Chest pain

CardioGard Cannula Risks
The CardioGard Cannula risks are estimated to be similar to the complications that may be seen with standard heart-lung bypass machine procedures. These complications may include but are not limited to:
•  Allergic reaction to the cannula materials
•  Bleeding, which could be substantial and require blood transfusions
•  Blood clots, which can lead to partial or complete blockage of a blood vessel
•  Collapsed lung (pneumothorax)
•  Damage to the aorta, which can cause bleeding
•  Death
•  Excess fluid around the heart or lungs that could reduce heart or lung function
•  Heart damage or failure
•  Heart rhythm problems that need to be treated
•  Infection (wound, bloodstream)
•  Kidney problems or failure
•  Loss of blood flow to a limb or other vital organs
•  Respiratory failure
•  Stroke or other neurological damage

Edwards Embol-X Embolic Protection Device Risks
The potential risks associated with the use of the Edwards Embol-X embolic protection device (as with other invasive cardiac surgery devices) include, but are not limited to, the following:
•  Allergic reaction to the cannula materials
•  Bleeding, which could be substantial and require blood transfusions
•  Blood clots, which can lead to partial or complete blockage of a blood vessel
•  Damage to the aorta, which can cause bleeding
•  Damage to the heart's electrical system or nearby tissues resulting in the need for a permanent pacemaker
•  Damage to structures surrounding the heart
•  Death
•  Excess fluid around the heart or lungs that could reduce heart or lung function
•  Heart attack or heart failure
•  Heart rhythm problems that need to be treated
•  Infection (wound, bloodstream)
•  Kidney problems or failure
•  Loss of blood flow to a limb or other vital organs
•  Respiratory failure
•  Stroke or other neurological damage

DWI MRI Risks
Participants must inform the staff of any metal or electronic devices they have in their bodies (such as a pacemaker or a metallic joint) before the MRI to ensure their safety.
Participants may experience some discomfort during the DWI procedure because they will have to lie still for a long period of time. The machine will create humming and thumping noises throughout the scan which may be unpleasantly loud. Participants may also experience some feelings of claustrophobia during the procedure.

Other Assessment Risks
Some people feel uncomfortable when answering questions about their mood or quality of their life. Though it is always better to have fully completed questionnaires, participants do not need to answer any questions that make them feel uncomfortable.

Confidentiality
A risk of taking part in this study is the possibility of a loss of confidentiality. Loss of confidentiality includes having personal information shared with someone who is not on the study team and was not supposed to see or know about this information. The study team has a process in place to protect participants' confidentiality.

What are the possible benefits of being in this study?
While participants may not personally benefit from this study, the researchers may collect valuable information that might protect other patients undergoing AVR surgery in the future.

How long will I be in the study?
Participants will be asked to continue in this study for 90 days following their AVR surgery.

What are the costs to be in this study?
Taking part in this study will not involve additional costs to participants. All study specific tests will be paid for by the study sponsor. Participants and/or their insurance companies will have to pay for any costs that are part of regular medical care. Anything not paid by health insurance for medical care will be billed directly to participants for payment.

Participants will not receive any compensation for participation in this research study.

Who is funding this research?
This research is being supported by a research grant from the following government programs:
•  National Heart, Lung, and Blood Institute (NHLBI)
•  National Institute of Neurological Disorders and Stroke (NINDS)
•  Canadian Institutes of Health Research (CIHR)

For Further Information about the Study and Enrollment

If you are interested in participating in this research you may contact one of the CTSN participating sites.
For contact information and more information about this study, please visit
https://clinicaltrials.gov/ct2/show/NCT02389894

For any additional questions, you may contact the Data Coordinating Center at the Icahn School of Medicine at Mount Sinai in New York City:
•  Ellen Moquete, RN, BSN, ellen.moquete@mountsinai.org, 212-659-9651 or
•  Anlami Shaw, MBA, Anlami.shaw@mountsinai.org, 212-659-9699 or

GCO # 08-1078(9); Current IRB approval period 1/20/17-1/19/18

Principal Investigator: Annetine C. Gelijns, PhD