STUDY TITLE: EVALUATING THE BENEFIT OF CONCURRENT TRICUSPID VALVE REPAIR DURING MITRAL SURGERY
Current Status: Enrollment Complete
Purpose
The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. What is not known with certainty, but what will be tested in this study, is whether patients with a smaller amount of leakage of the tricuspid valve (mild or moderate TR) would benefit from the repair in addition to the mitral valve surgery. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.
Why Repair the Valve in Patients with Mild to Moderate Tricuspid Leakage, who undergo Mitral Surgery?
• Mild to moderate TR may develop into more severe TR over time.
• We know that tricuspid repair is effective in controlling TR, and that this effect can be long lasting, preventing the development of severe TR.
Why not Repair Mild to Moderate Tricuspid Regurgitation in Patients, who undergo Mitral Surgery?
• In many patients, having mild to moderate TR results in no symptoms or other medical problems.
• Adding tricuspid valve surgery to the planned mitral surgery will lengthen the overall operation time.
How Many Patients will Participate?
There will be a total of 400 patients enrolled in this study in a number of medical centers (up to 40) across the United States, Canada and Germany.
Selected Study Procedures
Baseline Testing and Determination of Eligibility
First you will be asked to perform several tests, including an echocardiogram, which will use ultrasound (sound waves) to take pictures of your heart. The amount of tricuspid valve leakage observed on your echocardiogram will determine whether or not you are eligible to participate in this study.
You will also be asked to complete a six-minute walk test. This test will measure the distance you are able to walk in a hallway within six minutes. This test will be supervised by clinicians who may stop the test if it is in your best interest.
Treatment Assignment
The process of determining whether you will or will not receive the tricuspid valve repair in addition to the planned mitral valve surgery will occur while you are in the operating room and will be made using a scientific process (which involves random assignment, much like a coin toss). A scientific process is used to help make sure that the two treatment groups (mitral valve surgery with and without tricuspid valve repair) are made up of very similar patients. The chance that you will be selected to receive the tricuspid valve repair in addition to your planned mitral surgery is 50% or 1 in 2. You will be notified about whether or not you underwent the tricuspid valve repair in addition to the planned mitral valve surgery after your operation is over.
Brief Description of the Surgeries
All participants will undergo standard general anesthesia for heart surgery and have an incision made through the breast bone to expose the heart. All patients will be placed on the heart-lung machine (cardiopulmonary bypass) to support their heart and lung function while the heart is stopped during the valve repair. Mitral valve surgery will be performed using standard surgical techniques. Following mitral valve surgery, those patients who were assigned to this procedure alone will be taken to the intensive care unit for recovery. Those patients assigned to tricuspid valve repair will undergo a standard tricuspid valve repair before leaving the operating room. This will involve sewing a surgical ring to the tricuspid valve to control the amount that it opens to prevent leakage. The steps in performing each of the operations are standard of care and would be performed in the manner described here whether or not you were enrolled in the study.
Evaluation and Follow-up Visits and Phone Calls
After the surgery, all patients, regardless of whether their tricuspid valve was repaired or not, will have an echocardiogram before discharge from the hospital and will then be asked to return for an outpatient evaluation at 30 days and again at 6, 12, and 24 months.
At 36, 48 and 60 months after your surgery, the study team will contact you to ask a few questions about your health and any hospitalizations or illnesses you may have had since your previous visit or previous phone call with the study team. If the team is unable to reach you by phone, they will check your medical records to obtain any available information on your health status.
How Long Does the Research Last?
Your participation in this research study is expected to last 60 months after surgery.
Risks
The research involves standard surgical procedures. The health risks for you are the same whether you have these procedures as a participant in the research study or outside of the research study. One of the aims of the research is to see if there are differences in the risk of the following complications between the two treatment groups.
Infection may occur at the operative or other sites. Less commonly, the infection can involve the blood and spread throughout the body.
Kidney Problems or Failure
Loss of kidney function may occur following surgery. In most cases this loss is reversible, and over a period of time, your kidneys may return to the state they were in prior to the surgery.
Stroke
A stroke may occur if blood supply to the brain is impaired. The level of impairment depends on the location and size of the stroke.
Fluid Collection in the Space Surrounding the Heart
All surgeries performed on the heart can lead to fluid leaking into the space surrounding the heart known as the pericardial space. In most cases this will go away by itself, however, if the fluid collection is large enough it could compress the heart and affect your circulation.
Bleeding
As with all surgeries, internal bleeding after the surgery may occur.
Abnormal Heart Rhythms
Heart surgery itself can result in abnormal (irregular) heart rhythms that need to be treated.
Liver Problems or Failure
Following surgery it is possible that your liver may lose some or all of its ability to function normally. In most cases, this loss is reversible.
Heart Attack (Myocardial Infarction)
Heart attack is a known risk associated with heart surgery.
Breathing Problems
Lung complications can occur following surgery, affecting your ability to breathe on your own.
Blood Clot (Thromboembolic Event)
There is the risk that you will form a blood clot in your veins, with a chance that it could travel to your lungs and cause breathing problems. This event is known as a thromboembolism.
Discomfort and Pain
Open heart surgery does involve post-operative pain. Your participation in this study will not increase the discomfort and pain associated with your treatment.
Loss of confidentiality
A risk of taking part in this study is the possibility of a loss of confidentiality. Loss of confidentiality includes having your personal information shared with someone who is not on the study team and was not supposed to see or know about your information. The study team plans to protect your confidentiality. Their plans for keeping your information private are described in the ‘confidentiality’ section of this consent form.
Six Minute Walk Test
You may feel uncomfortable, short of breath, or tired during the six minute walk test. This test may be stopped at any time by the clinician supervising your progress if it is in your best interest.
Benefits
You may or may not receive personal (direct) benefit from taking part in this study. The results of this study may provide important information for the medical treatment for future patients with heart conditions similar to yours.
Compensation
You will not receive any payment or other compensation for participating in this study.
Additional Costs
There is no additional cost to you for your participation in this study. You and your health insurance company remain responsible for any costs that are part of your regular medical care, such as your surgery, the procedures, tests and visits you would have received if you were not part of this study, and hospitalizations. Tests and assessments conducted only for the purpose of this study, such as the six-minute walk, some echocardiograms, and quality of life assessments, will be paid from the research budget.
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/NCT02675244
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
GCO # 08-1078(10); Current annual IRB approval period: 2/16/20-2/15/21
Principal Investigator: Annetine C. Gelijns, PhD
