End-stage Heart Failure Awaiting VAD ImplantationCOVADISNCT01244321
COVADIS Pilot Trial: COseal in Ventricular Assist DevIceS
An observational study of End-stage Heart Failure Awaiting VAD Implantation, run by German Heart Institute at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End-stage Heart Failure Awaiting VAD Implantation
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2010to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage heart failure, awaiting heart transplantion, with need for VAD (ventricular assist device)
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Berlin
Berlin, 13353
Roland Hetzer, MD PhD
About this study
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)
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.
Read the 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.
- Keywords
- End stage heart failure, heart transplantation, Ventricular assist device, Patients with end stage heart failure, awaiting heart transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| CoSeal Control Group | Subjects who had a LVAD for more than 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and severity of adhesions
Assessment of adhesions using a scoring system, assessing six different sites.
Measured: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)
Secondary outcomes (3)
Bleeding
Hemostasis time (START: off pump time; STOP: skin closure); bleeding volume Tansfusions of blood related products - defined as quantity of blood related product transfusions (ml) administered to the patient from skin incision to discharge or 30 days after surgery, whichever comes first, for both first and second study operation Blood loss in chest drains - defined as amount of blood lost in the chest drains from postoperative time to discharge or 30 days after surgery, whichever comes first.
Measured: At the moment of VAD-Removal/Transplantation
Clinical outcome
Surgery times (duration) during explantation/transplantation
- Dissection time (START: skin incision; STOP: on-pump time)
- Dissection time by region dissected, calculated as time to go to bypass (START: skin incision; STOP: initiation of bypass) by number of the investigational regions with adhesions dissected in this interval
- Time to VAD removal (START: skin incision; STOP: time of VAD removal from patient's chest at 2nd study operation)
- Length of operation (START: skin incision; STOP: chest closure).
Measured: At the moment of VAD removal/transplantation (>6 weeks after VAD implantation)
Adhesion related
- Percentage of patients with grade 3 adhesions at VAD grafts
- Mean incidence score
- Mean adhesion severity score
- Percentage of sites free of adhesions
- Time required for adhesion dissection - pure dissection time before and after the CPB
Measured: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart Failure Awaiting VAD ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Roland Hetzer, MD, PhD, Principal investigator, Deutsches Herzzentrum Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244321
- Sponsor's protocol ID
- COVADIS002
- Acronym
- COVADIS
- Status last verified
- Jan 2015
- First submitted
- 18 Nov 2010
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01244321
- Acronym / sponsor ID
- COVADIS / COVADIS002
- Keywords
- End stage heart failure, heart transplantation, Ventricular assist device, Patients with end stage heart failure, awaiting heart transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| CoSeal Control Group | – | –Subjects who had a LVAD for more than 6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage heart failure, awaiting heart transplantion, with need for VAD (ventricular assist device)
Key inclusion criteria (6 listed)
- 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.
- Written informed consent obtained from the subject prior to participation in the study
- At least 18 years of age
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence and severity of adhesions
Time frame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)
Assessment of adhesions using a scoring system, assessing six different sites.
3 secondary outcomes
Bleeding
Time frame: At the moment of VAD-Removal/Transplantation
Clinical outcome
Time frame: At the moment of VAD removal/transplantation (>6 weeks after VAD implantation)
Adhesion related
Time frame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
- Homepage of Deutsches Herzzentrum BerlinLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Hetzer, MD, PhD principal investigator
Deutsches Herzzentrum Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Heart Failure Awaiting VAD Implantation, run by German Heart Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roland Hetzer, MD, PhD (++49/30/4593 2000, hetzer@dhzb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and severity of adhesions (time frame: At the moment of VAD-Removal/Transplantation (>6 weeks after VAD implantation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.