Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

This is an observational study, and does not involve medicines. You (as a participant 18 and older) or your child will still take medicines normally needed and as prescribed by your doctor.

We would like to follow you/your child in this study throughout your/your child’s life so that we can evaluate long-term outcomes of Tricuspid Atresia. By agreeing to participate in this study, you are giving permission for the study doctors to contact you and/or your child as mentioned below. If you are a parent, once your child is old enough to understand and participate in the consent process, we will ask if he/she is willing to continue in the study.

If you/your child participate in this study, your/your child’s medical chart will be reviewed for certain information. Information regarding your/your child’s name, date of birth, contact information, surgery, and hospitalization will be sent to the CHSS Data Center. Information such as your/your child’s diagnosis, anatomy, surgical procedures, and follow-up visits will be entered into a password-protected computer database. All of this information will be kept confidential.

Once this information is collected and sent to CHSS, a unique study identification number will be created for you/your child so that personal health information will not be used directly in any further analysis or correspondence.

A specially trained staff member from the CHSS Data Center will call you to welcome you/your child into the study. Then, every year, a staff member from CHSS or Sick Kids will contact you, by phone and/or mail, to ask how you/your child are doing and ask that you fill out a short survey. The survey, which takes 10 to 15 minutes, will have questions about your/your child’s health, quality of life, activity level and medical care.

Information from your/your child’s medical records will also be collected each year and sent to the CHSS Data Center.
Your/your child’s information will be analyzed together with information from other people with the same heart defect from collaborating centers. It will be used to determine the impact of patient factors and different treatments on results and to examine the overall health status of children with Tricuspid Atresia.

You, as a parent/guardian or participant, will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered.