The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
Stopped early · Not applicable
Conditions studied: Heart Failure, Ventricular Dysfunction
In brief
The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery. This study is evaluating CoSeal™ when it is applied to various areas of the heart during the surgery to implant a Left Ventricular Assist Device (LVAD). the investigators are looking for evidence which indicates that CoSeal™ may be useful in reducing or stopping bleeding, the occurrence of micro emboli (small particles of air or blood), and the formation of cardiac adhesions (scar tissue strands that may form around the heart in the area of a previous LVAD operation) in patients who undergo LVAD implantation surgery.
Key facts
- Study ID
- NCT01605019
- Run by
- The Methodist Hospital Research Institute
- People needed
- 4
- Starts
- 2012-06-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2018-08-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject or the subject's legal representative has signed the IRB approved study informed consent.
- Subject is greater than or equal to 18 years of age.
- Subject has a known indication for implantation of a LVAD and meets the requirements for its implantation.
- Subject who, in the opinion of the investigator, will not require removal of the LVAD earlier than 6 weeks after implantation.
You may not qualify if…
- Subject requires the concomitant use of any other anti-adhesion product during LVAD implantation.
- Subject has an immune system disorder, immuno-deficiencies, or immuno-suppression.
- Subject has known hypersensitivity to the study device, CoSeal™, or any component of the study device.
- Subject is currently participating in another clinical trial for adhesion prevention or sealing evaluation and/or who has received such an investigational drug or device within the previous 30 days.
- Subject has previously undergone a LVAD implantation/explantation.
- Subject is pregnant or currently breast-feeding.
Where it is running
- Texas Heart Institute — Houston, Texas, United States
- The Methodist Hospital DeBakey Heart & Vascular Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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