Welcome to the STS-ACC TVT Registry Case Scenario, where we will focus on information that will help in determining registry inclusion. As a disclaimer, the mock clinical trial portrayed in this case scenario is completely fictitious and was made up for demonstration purposes only. To begin, let's look at the Registry Inclusion Criteria Resource Guide located under the Resources tab on the left navigation bar and select Documents. From here, find the User Guide Documents section and download the Registry Inclusion Criteria. A patient would be entered into the registry if they are at least 18 years of age on arrival to the facility. There must be an intent to perform a transcatheter valve procedure inclusive of aortic valve replacement, mitral valve repair, mitral valve replacement, tricuspid valve repair, or tricuspid valve replacement when the patient enters the procedure room. The device must be FDA approved, otherwise known as commercially available. And lastly, the device must be inserted by percutaneous access or puncture of a great vessel. The registry excludes procedures for patients under 18 years of age on the day of arrival, or patients who have an insertion of a device not yet commercially available, or patients who are enrolled or participating in a clinical trial that studies a transcatheter valve clip or an annular reduction device for FDA approval, or patients who have an insertion of a device via direct visualization of the native valve during an open heart procedure or any procedure performed on the pulmonic valve. The first question for this case scenario is one similar to many received by the registry over the years. The intent of this case scenario is to provide sites with tools to assist in determining inclusion in the TBT registry. We will show sites how to utilize the inclusion criteria document, as well as the website for clinicaltrials.gov, which is an invaluable resource of clinical trial information. Let's begin. Our facility has a patient enrolled in the Fantastic Mitral Clip trial. Would this record be entered into the TBT registry? And so when trying to determine if the Fantastic Mitral Clip trial is studying a commercially available device, the first place to look is the manufacturer's website. If the site does not have information on the device, it may be because the device is not FDA approved. Another source of information is clinicaltrials.gov. In the search for condition or disease, enter valve disease, heart, then enter the study or trial name. Know that there may be multiple trials with the same name, so make sure you locate the correct one. And if no information is found on either the manufacturer's website or on clinicaltrials.gov, look up the name of the study trial on the Internet. In reviewing the device on the clinicaltrials.gov site, it is determined that the Fantastic Mitral Clip device has not yet been approved by the FDA. Would the patient be entered into the registry? Please take a few moments before responding. And the answer is no. The patient would not be entered into the registry because the device is not commercially available. Thus, it does not meet transcatheter mitral valve repair criteria. And a bonus question. The Fantastic Mitral Clip trial has an arm of the study that compares the non-FDA approved trial device to an FDA approved mitral valve clip device, the PASCAL. Are patients in the PASCAL arm of the trial entered into the registry? Again, please take a few moments before responding. And the answer is no. Per direction of the steering committee, patients who receive a commercially available device as an arm of study reviewing a non-FDA approved device are not entered into the registry. This is supported in the registry inclusion criteria document as well. Although a rare occurrence, there have been questions on inclusion if a transcatheter valve is inserted during open heart surgery. Is this patient entered into the TVT registry? Please take a few moments before responding. When a transcatheter valve is inserted during open heart surgery where the valve is exposed to direct visualization, it is not entered into the registry as inclusion criteria is not met. Thank you for viewing the TVT registry case scenario.

STS-ACC TVT Registry

Data Quality Report

follow-up records

base submission

one-year follow-up