COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS

NCT ID: NCT01244321

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2018-02-28

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 cardiac adhesion formation in patients submitted to VAD procedures.

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 same time, the duration of the implantation period has lengthened dramatically. When removing VADs after a long period, surgeons face severe pericardial adhesions at the mediastinum level and of the surrounding tissue due to the inflammatory response. During resternotomy, dissection of these adhesions increases surgical time and can be a source of lesions on the cardiac or vascular structures and of severe bleeding at the moment of transplantation or when the device is removed.

Many products have been used to prevent or reduce adhesions but an ideal antiadhesive treatment has remained elusive. CoSeal®, a licensed synthetic hydrogel (Baxter, USA) has been shown to reduce pericardial adhesions in a limited series of reoperations.

Conditions

End-stage Heart Failure Awaiting VAD Implantation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

CoSeal Group

Subjects with indication for LVAD implantation, meeting the requirements for LVAD implantation. Patients for whom LVAD removal is anticipated not earlier than 6 weeks after LVAD implantation.

No interventions assigned to this group

CoSeal Control Group

Subjects who had a LVAD for more than 6 weeks.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Written informed consent obtained from the subject prior to participation in the study

2. At least 18 years of age

3. 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.

1. Written informed consent obtained from the subject prior to participation in the study

2. At least 18 years of age

3. Subjects who had a LVAD for more than 6 weeks.

Exclusion Criteria

1. Concomitant use of any other anti-adhesion product

2. Immune system disorders, immuno-deficiencies or immuno-suppression

3. Known hypersensitivity to components of the study product

4. 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

5. Patients who were previously subject to another LVAD implantation/explantation

6. Pregnant or breast-feeding women.

1. Known use of any other anti-adhesion product during VAD implantation

2. Immune system disorders, immuno-deficiencies or immuno-suppression

3. 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

4. Patients who were previously subject to another LVAD implantation/explantation

5. Pregnant or breast-feeding women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

German Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roland Hetzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Berlin, Germany

Locations

Deutsches Herzzentrum Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Roland Hetzer, MD, PhD

Role: CONTACT

hetzer@dhzb.de

++49/30/4593 2000

Thomas Krabatsch, MD, PhD

Role: CONTACT

krabatsch@dhzb.de

++49/30/4593 2000

Related Links

http://www.dhzb.de

Homepage of Deutsches Herzzentrum Berlin

Other Identifiers

COVADIS002

Identifier Type: -

Identifier Source: org_study_id