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The Gen 2 CorCap Study
The Gen 2 CorCap™ Study is a US clinical research study (also called a clinical trial) which has been approved by the US Food and Drug Administration. This study will investigate how safe the Gen 2 CorCap device is and if it may help to improve the lives of patients with heart failure.
The Gen 2 CSD is the second generation design of the CorCap CSD. The changes made to this new device will allow the Gen 2 CSD to be placed on your heart through a surgical incision about 3-5 inches long that is made between your ribs. This procedure is called a thoracotomy. It is considered less invasive (meaning that a smaller incision is made) than a sternotomy (a surgical incision through your sternum or breast bone). The Gen 2 CSD also has a self attaching hem (like an elastic band) so that your doctor does not need to stitch the device to your heart. It is hoped that these design changes may improve the benefits you receive and lower the risks you may have due to the surgery.
In this study, patients who have been diagnosed with heart failure, and meet the specific medical inclusion criteria are eligible to participate. If the study doctors and clinical study staff determine that you are eligible, and you decide to participate in the study after learning about all of the study procedures and risks, you would undergo a surgical procedure to have the Gen 2 CorCap device placed around your heart.
To see if you may qualify for participation in this clinical study, please take this short survey
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