Neurocognitive Outcome After Aortic Valve ReplacementELMARNCT01128751
Elimination of Microemboli During Aortic Valve Replacement
A study testing Embol-X intra-aortic emboli filter and DBT dynamic bubble trap in people with Neurocognitive Outcome After Aortic Valve Replacement, run by University of Giessen at 3 sites in Germany.
Trial summary
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurocognitive Outcome After Aortic Valve Replacement
- What is being tested?
- Embol-X intra-aortic emboli filter and DBT dynamic bubble trap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Elective aortic valve replacement
- Informed consent
- German language
Who cannot join
- Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
- Contraindication against MRI assessment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites, 3 recruiting
- Recruiting
University Clinic Giessen
35392 Giessen, Hesse, 35392
Jörn Bohn
- Recruiting
Johann Wolfgang Goehte University Clinic
60590 Frankfurt, Hesse, 60590
Annika Löffler
- Recruiting
Kerckhoff Clinic
61231 Bad Nauheim, Hesse, 61231
Niko Schwarz, PhD
About this study
Official title: ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.
- Being tested
- Embol-X intra-aortic emboli filter, DBT dynamic bubble trap, Control group
- Keywords
- Cognition, Neuroprotection, Cardiopulmonary bypass, Aortic valve replacement, Micro-emboli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embol-X intra-aortic emboli filterProcedure or surgery
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
DBT dynamic bubble trapProcedure or surgery
Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
Control groupProcedure or surgery
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
| Study group | Role | What they receive |
|---|---|---|
| Embol-X | Active comparator | Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery. Receives: Procedure: Embol-X intra-aortic emboli filter |
| DBT dynamic bubble trap | Active comparator | Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery Receives: Procedure: DBT dynamic bubble trap |
| Control group | No intervention | In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological assessment 1
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Measured: 3 weeks to 1 day before intervention
Neuropsychological assessment 2
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Measured: 3 months (+/- 1 week) post intervention
Secondary outcomes (1)
MRI lesions detected after surgery
In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)
Measured: 2-6 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive Outcome After Aortic Valve ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128751
- Sponsor's protocol ID
- P41/09// A67/09
- Acronym
- ELMAR
- Status last verified
- May 2010
- First submitted
- 18 May 2010
- Last updated
- 24 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01128751
- Acronym / sponsor ID
- ELMAR / P41/09// A67/09
- Keywords
- Cognition, Neuroprotection, Cardiopulmonary bypass, Aortic valve replacement, Micro-emboli
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (estimated)
- First posted
- 24 May 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.
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Embol-X | Active comparator | Procedure: Embol-X intra-aortic emboli filterPatients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery. |
| DBT dynamic bubble trap | Active comparator | Procedure: DBT dynamic bubble trapPatients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery |
| Control group | No intervention | Procedure: Control groupIn comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Elective aortic valve replacement
- Informed consent
- German language
Key exclusion criteria (2 listed)
- Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
- Contraindication against MRI assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embol-X intra-aortic emboli filterPatients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery. | Procedure or surgery | Embol-X |
| DBT dynamic bubble trapPatients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery | Procedure or surgery | DBT dynamic bubble trap |
| Control groupIn comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery | Procedure or surgery | Control group |
Primary outcome
Neuropsychological assessment 1
Time frame: 3 weeks to 1 day before intervention
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Neuropsychological assessment 2
Time frame: 3 months (+/- 1 week) post intervention
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
1 secondary outcome
MRI lesions detected after surgery
Time frame: 2-6 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2010.
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embol-X intra-aortic emboli filter and DBT dynamic bubble trap in people with Neurocognitive Outcome After Aortic Valve Replacement, run by University of Giessen at 3 sites 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 4 inclusion and 2 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 24 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Niko Schwarz, PhD (+49(0)6032/999- ext. 5811, niko.schwarz@neuro.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological assessment 1 (time frame: 3 weeks to 1 day before intervention). The study lists 2 primary outcomes in all. 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 24 May 2010.