Clinical trial NCT01244321: COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS
Official title: A Controlled, Single-Center Clinical Pilot Study to Evaluate the Performance of CoSeal as a Barrier for Adhesion Prevention in Patients Submitted to Ventricular Assist Device VAD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-stage Heart Failure Awaiting VAD Implantation
Keywords: End stage heart failure
heart transplantation
Ventricular assist device
Patients with end stage heart failure
awaiting heart transplantation
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2010-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end stage heart failure, awaiting heart transplantion, with need for VAD (ventricular assist device)

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.

Eligibility criteria: Inclusion criteria (CoSeal group):

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.

Inclusion criteria (CoSeal control group):

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 (CoSeal group):

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.

Exclusion criteria (Co Seal control group):

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.

Primary outcomes:
measure: Presence and severity of adhesions
timeFrame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)
Secondary outcomes:
measure: Bleeding
timeFrame: At the moment of VAD-Removal/Transplantation
measure: Clinical outcome
timeFrame: At the moment of VAD removal/transplantation (>6 weeks after VAD implantation)
measure: Adhesion related
timeFrame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
Study officials:
affiliation: Deutsches Herzzentrum Berlin, Germany
name: Roland Hetzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: