Status:
UNKNOWN
COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS
Lead Sponsor:
German Heart Institute
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End-stage Heart Failure Awaiting VAD Implantation
Eligibility:
All Genders
18-70 years
Brief Summary
The objective of this controlled, non-randomized, single-center pilot study (CoSeal arm prospective)study is to evaluate the efficacy of the synthetic surgical hydrogel CoSeal® in the prevention of ca...
Detailed Description
In the past decade the use of ventricular assist devices) (VADs) for bridging to heart transplantation (HTx) or, in some cases, to recovery of the ventricular function has increased and, during the sa...
Eligibility Criteria
Inclusion
- Inclusion criteria (CoSeal group):
- Written informed consent obtained from the subject prior to participation in the study
- At least 18 years of age
- Subjects with indication for LVAD implantation, meeting the requirements for LVAD implantation. Patients for whom the investigator anticipates LVAD removal not earlier than 6 weeks after LVAD implantation.
- Inclusion criteria (CoSeal control group):
- Written informed consent obtained from the subject prior to participation in the study
- At least 18 years of age
- Subjects who had a LVAD for more than 6 weeks.
- Exclusion criteria (CoSeal group):
- Concomitant use of any other anti-adhesion product
- Immune system disorders, immuno-deficiencies or immuno-suppression
- Known hypersensitivity to components of the study product
- Patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days
- Patients who were previously subject to another LVAD implantation/explantation
- Pregnant or breast-feeding women.
- Exclusion criteria (Co Seal control group):
- Known use of any other anti-adhesion product during VAD implantation
- Immune system disorders, immuno-deficiencies or immuno-suppression
- Patients concurrently participating in another clinical trial for adhesion prevention or sealing evaluation and having received such an investigational drug or device within the previous 30 days
- Patients who were previously subject to another LVAD implantation/explantation
- Pregnant or breast-feeding women.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01244321
Start Date
December 1 2010
End Date
February 1 2018
Last Update
January 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353