More attention to your health from the research team than patients not enrolled in the trial
Clinical trial long term follow-up

Thank you for your continued participation
When you chose to participate in an Edwards Lifesciences clinical trial, you joined a global community of patients and healthcare providers.
Your participation helps doctors and researchers learn more about treating heart valve disease and heart failure. The follow-up visits are an important way for your research team to check how your heart is doing over time. These visits also provide information that can help in the treatment of future patients like you.
Thank you for participating in a clinical trial and attending your follow-up visits. If you have any questions or if it becomes hard to come to your visits for any reason, please contact your research team to discuss possible solutions.
Why long term follow-up is critical
Listen to 3 key clinical trial physicians talk about the importance of attending your follow-up visits.
Your potential benefits of participating in a clinical trial
The success of clinical trials depends largely on the ongoing participation of patients—each and every person. Here are some potential benefits of continuing to participate:
Personalized medical care and monitoring through the duration of your participation
Experts in their field overseeing the clinical trial and helping patients like you
What to expect throughout your clinical trial journey
As a reminder of your commitment to the clinical trial, below you will find an explanation of the three phases of the trial and what occurs in each phase.

Patient consent and treatment
The doctor looks at your medical history and performs medical tests to see if you qualify for the clinical trial. If you qualify, your research team will explain the procedure, potential risks, follow-up schedule, and other important information before you review and accept the Informed Consent Form.
Depending on the design of the clinical trial, you may have a procedure or you may be carefully monitored without intervention, which is known as clinical surveillance.

Patient follow-up
You attend follow-up visits on a frequency determined by your research team. If you are experiencing any changes in your health, please contact your research team.
Each visit may involve a check of your vital signs, echo imaging (ultrasound), and other tests as deemed appropriate by your research team. Echocardiograms are ultrasounds of your heart and are an important way for doctors to monitor how your heart functions over time.

Results reporting
The information obtained from every follow-up visit and echo is important to the trial.
Your information is combined with that of all participants, creating a foundation of data to be evaluated by the research team.
Trials that achieve their objectives are then reviewed by the Food & Drug Administration (FDA) with the potential for the treatment to become available to all patients.

We're here for you
We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.
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