StrokeLABELNCT02985463
Left Atrial Appendage Occlusion and Biomarker Evaluation
An observational study of Stroke and Atrial Fibrillation, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation, Bleeding
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from non valvular atrial fibrillation with a contraindication for oral anticoagulation (i.e. bleeding) being eligible of percutaneous implantation of LAA occlusion devices.
Who may be able to join
- non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke from the LAA
- contraindication for the therapy with oral anticoagulants:
- refusal to take oral anticoagulation
- HasBled-score more than 3
- prior bleedings under oral anticoagulation
Who cannot join
- under 18 years
- severely reduced left atrial function
- mechanical heart valve
- pulmonary embolism
- deep vein thrombosis
- myocardial infarction within the last 3 months
Show all 14Show fewer
- electrical cardioversion within 30 days after potential occluder implantation
- atrial septum defect or interventional/surgical occlusion of ASD
- status after heart transplant
- symptomatic carotid artery stenosis
- transient ischemic attack (TIA) or stroke within last 30 days
- intracerebral bleeding within the last 2 months
- acute infection
- existing or planned pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Centre Mannheim
Mannheim, Baden-Wurttemberg, 68167
About this study
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up.
Read the detailed description
This study will evaluate the changes of different types of biomarkers before and after successful percutaneous implantation of an LAA occlusion device.
Biomarker evaluation will focus on blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.
- Conditions
- Stroke, Atrial Fibrillation, Bleeding
- Medical subject headings
- Stroke, Atrial Fibrillation, Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker levels before successful LAA occlusion device implantation
Measured: 24 hours before intervention
Secondary outcomes (2)
Biomarker levels after successful LAA occlusion device implantation
Measured: mid-term follow up at 6 months
Changes of biomarker expression before and after device implantation over mid-term follow-up, depending of complete, incomplete occlusion, imaging data (transesophageal echocardiography, computed tomography)
Measured: mid-term follow up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJun 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Behnes, Universitätsmedizin Mannheim
- Investigators
- Ibrahim Akin, Prof., Study director, University Medical Center Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985463
- Sponsor's protocol ID
- 2014-402M-MA-§ 23b MPG
- Acronym
- LABEL
- Status last verified
- Aug 2020
- First submitted
- 3 Dec 2016
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Behnes M, Akin I, Sartorius B, Fastner C, El-Battrawy I, Borggrefe M, Haubenreisser H, Meyer M, Schoenberg SO, Henzler T. --LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography. BMC Med Imaging. 2016 Mar 24;16:25. doi: 10.1186/s12880-016-0127-y.
PubMed 27009279Fastner C, Behnes M, Sartorius B, Yildiz M, Mashayekhi K, El-Battrawy I, Lehmann R, Baumann S, Becher T, Borggrefe M, Akin I. Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study. BMC Cardiovasc Disord. 2016 Jan 28;16:25. doi: 10.1186/s12872-016-0200-z.
PubMed 26822890Rusnak J, Behnes M, Saleh A, Fastner C, Sattler K, Barth C, Wenke A, Sartorius B, Mashayekhi K, Hoffmann U, Yuecel G, Lang S, Borggrefe M, Akin I. Interventional left atrial appendage closure may affect metabolism of essential amino acids and bioenergetic efficacy. Int J Cardiol. 2018 Oct 1;268:125-131. doi: 10.1016/j.ijcard.2018.05.031. Epub 2018 Jun 1.
PubMed 29861102Fastner C, Behnes M, Sartorius B, Wenke A, Lang S, Yucel G, Sattler K, Rusnak J, Saleh A, Barth C, Mashayekhi K, Hoffmann U, Borggrefe M, Akin I. Interventional Left Atrial Appendage Closure Affects the Metabolism of Acylcarnitines. Int J Mol Sci. 2018 Feb 7;19(2):500. doi: 10.3390/ijms19020500.
PubMed 29414920
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Appendage Occlusion and Biomarker Evaluation
- ClinicalTrials.gov ID
- NCT02985463
- Acronym / sponsor ID
- LABEL / 2014-402M-MA-§ 23b MPG
- Conditions
- Stroke, Atrial Fibrillation, Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Dec 2016 (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.
"Left Atrial Appendage Occlusion and Biomarker Evaluation" (LABEL) is a single-center, prospective and observational study evaluating changes of the expression of biomarkers in eligible patients before and after percutaneous implantation of a left atrial appendage (LAA) occlusion device at mid-term follow-up.
Detailed description
This study will evaluate the changes of different types of biomarkers before and after successful percutaneous implantation of an LAA occlusion device.
Biomarker evaluation will focus on blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from non valvular atrial fibrillation with a contraindication for oral anticoagulation (i.e. bleeding) being eligible of percutaneous implantation of LAA occlusion devices.
Key inclusion criteria (5 listed)
- non valvular atrial fibrillation, that makes anticoagulation to prevent embolic stroke from the LAA
- contraindication for the therapy with oral anticoagulants:
- refusal to take oral anticoagulation
- HasBled-score more than 3
- prior bleedings under oral anticoagulation
Key exclusion criteria (14 listed)
- under 18 years
- severely reduced left atrial function
- mechanical heart valve
- pulmonary embolism
- deep vein thrombosis
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
Biomarker levels before successful LAA occlusion device implantation
Time frame: 24 hours before intervention
2 secondary outcomes
Biomarker levels after successful LAA occlusion device implantation
Time frame: mid-term follow up at 6 months
Changes of biomarker expression before and after device implantation over mid-term follow-up, depending of complete, incomplete occlusion, imaging data (transesophageal echocardiography, computed tomography)
Time frame: mid-term follow up at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Background: PubMed 27009279Behnes M, Akin I, Sartorius B, Fastner C, El-Battrawy I, Borggrefe M, Haubenreisser H, Meyer M, Schoenberg SO, Henzler T. --LAA Occluder View for post-implantation Evaluation (LOVE)--standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography. BMC Med Imaging. 2016 Mar 24;16:25. doi: 10.1186/s12880-016-0127-y.
- Results publication: PubMed 26822890Fastner C, Behnes M, Sartorius B, Yildiz M, Mashayekhi K, El-Battrawy I, Lehmann R, Baumann S, Becher T, Borggrefe M, Akin I. Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study. BMC Cardiovasc Disord. 2016 Jan 28;16:25. doi: 10.1186/s12872-016-0200-z.
- Derived from this study: PubMed 29861102Rusnak J, Behnes M, Saleh A, Fastner C, Sattler K, Barth C, Wenke A, Sartorius B, Mashayekhi K, Hoffmann U, Yuecel G, Lang S, Borggrefe M, Akin I. Interventional left atrial appendage closure may affect metabolism of essential amino acids and bioenergetic efficacy. Int J Cardiol. 2018 Oct 1;268:125-131. doi: 10.1016/j.ijcard.2018.05.031. Epub 2018 Jun 1.
- Derived from this study: PubMed 29414920Fastner C, Behnes M, Sartorius B, Wenke A, Lang S, Yucel G, Sattler K, Rusnak J, Saleh A, Barth C, Mashayekhi K, Hoffmann U, Borggrefe M, Akin I. Interventional Left Atrial Appendage Closure Affects the Metabolism of Acylcarnitines. Int J Mol Sci. 2018 Feb 7;19(2):500. doi: 10.3390/ijms19020500.
- Individual participant dataSharing planned: No
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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.
Ibrahim Akin, Prof. study director
University Medical Center Mannheim
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 Stroke and Atrial Fibrillation, run by Universitätsmedizin Mannheim 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 5 inclusion and 14 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 27 Aug 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker levels before successful LAA occlusion device implantation (time frame: 24 hours before intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02985463, which also lists 4 linked publications.
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 27 Aug 2020; AzTrials last refreshed its copy on 2 Nov 2026.