Atrial FibrillationLAARGENCT02230748
Left-Atrium-Appendage Occluder Register - GErmany
An observational study of Atrial Fibrillation and Stroke, run by Stiftung Institut fuer Herzinfarktforschung at 4 sites in Germany.
Trial summary
Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation? Safety: How save is the implantation of LAA-Occluders? Effectiveness: How effective is implantation of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Stroke
- How many people
- 643 participants
- Where
- 4 sitesGermany
- Study dates
- Jul 2014to 27 Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with an performed or planned LAA -Occluder
Who may be able to join
- Intention to laa occluder
Who cannot join
- Missing informed consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinikum Coburg
Coburg, 96450
Institut für Herzinfarkforschung Ludwigshafen
Ludwigshafen, 67063
Universitätsmedizin Mannheim
Mannheim, 68167
Isar Herzzentrum
München, 80331
About this study
- Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice
- Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
- Safety: How save is the implantation of LAA-Occluders?
- Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice?
- Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?
Read the detailed description
LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed by an implantable medical device. In particular the following questions should be answered:
- Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
- Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in the long term course)? How frequent are bleeding complications and what is the relation of observed and expected bleeding complications (according HAS-BLED score)?
- Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice (in hospital and in the long term course)? How frequent are strokes and what is the relation of observed and expected strokes (according CHADS-VASC score)?
- Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- LAA, LAA-Occluder, Atrial Fibrillation, AF
- Medical subject headings
- Atrial Fibrillation, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: clinical events with LAA occlusion
Documentation of reasons for LAA Occluder Implantation.
Periprocedural and hospital: death, bleeding, pericardial effusion, reanimation, occluder dislocation and further complications.
Long term follow-up:: death, bleeding, pericardial effusion, reanimation, occluder dislocation, further complications and patients safety.
Measured: 1 year follow-up (optional 2,3,5 years)
Secondary outcomes (1)
Effectiveness: LAA occlusion
periprocedural and hospital: Sudden or unexpected death, stroke, TIA, systemic embolism, technical success.
Long term follow-up: Sudden or unexpected death, stroke, TIA, systemic embolism, patients satisfaction.
Measured: 1 year follow-up (optional 2,3,5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completion27 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jochen Senges, MD, Principal investigator, Stiftung Institut für Herzinfarktforschung (IHF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230748
- Sponsor's protocol ID
- LAARGE
- Acronym
- LAARGE
- Status last verified
- Sep 2018
- First submitted
- 29 Aug 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ansari U, Brachmann J, Lewalter T, Zeymer U, Sievert H, Ledwoch J, Geist V, Hochadel M, Schneider S, Senges J, Akin I, Fastner C. LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry. Clin Res Cardiol. 2024 Oct;113(10):1451-1462. doi: 10.1007/s00392-024-02376-8. Epub 2024 Jan 31.
PubMed 38294498Fastner C, Brachmann J, Lewalter T, Zeymer U, Sievert H, Borggrefe M, Weiss C, Geist V, Krapivsky A, Kaunicke M, Mudra H, Hochadel M, Schneider S, Senges J, Akin I. Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry. Clin Res Cardiol. 2020 Nov;109(11):1333-1341. doi: 10.1007/s00392-020-01627-8. Epub 2020 Mar 31.
PubMed 32236717
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left-Atrium-Appendage Occluder Register - GErmany
- ClinicalTrials.gov ID
- NCT02230748
- Acronym / sponsor ID
- LAARGE / LAARGE
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- LAA, LAA-Occluder, Atrial Fibrillation, AF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 3 Sep 2014 (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.
- Evaluation of safety and effectiveness of implantable LAA occluder in clinical practice
- Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
- Safety: How save is the implantation of LAA-Occluders?
- Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice?
- Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?
Detailed description
LAARGE aims to show the care reality of patients whose left atrial appendage (LAA) is closed by an implantable medical device. In particular the following questions should be answered:
- Indication: For which reasons is the indication for implantation of LAA-Occluder put for patients with atrial fibrillation?
- Safety: How save is the implantation of LAA-Occluders (procedural, in hospital and in the long term course)? How frequent are bleeding complications and what is the relation of observed and expected bleeding complications (according HAS-BLED score)?
- Effectiveness: How effective is implantation of LAA-Occluders in daily clinical practice (in hospital and in the long term course)? How frequent are strokes and what is the relation of observed and expected strokes (according CHADS-VASC score)?
- Concomitant treatment: Which concomitant treatment is prescribed for patients with LAA-Occluder?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with an performed or planned LAA -Occluder
Key inclusion criteria (1 listed)
- Intention to laa occluder
Key exclusion criteria (1 listed)
- Missing informed consent
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
Safety: clinical events with LAA occlusion
Time frame: 1 year follow-up (optional 2,3,5 years)
Documentation of reasons for LAA Occluder Implantation. Periprocedural and hospital: death, bleeding, pericardial effusion, reanimation, occluder dislocation and further complications. Long term follow-up:: death, bleeding, pericardial effusion, reanimation, occluder dislocation, further complications and patients safety.
1 secondary outcome
Effectiveness: LAA occlusion
Time frame: 1 year follow-up (optional 2,3,5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 38294498Ansari U, Brachmann J, Lewalter T, Zeymer U, Sievert H, Ledwoch J, Geist V, Hochadel M, Schneider S, Senges J, Akin I, Fastner C. LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry. Clin Res Cardiol. 2024 Oct;113(10):1451-1462. doi: 10.1007/s00392-024-02376-8. Epub 2024 Jan 31.
- Derived from this study: PubMed 32236717Fastner C, Brachmann J, Lewalter T, Zeymer U, Sievert H, Borggrefe M, Weiss C, Geist V, Krapivsky A, Kaunicke M, Mudra H, Hochadel M, Schneider S, Senges J, Akin I. Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry. Clin Res Cardiol. 2020 Nov;109(11):1333-1341. doi: 10.1007/s00392-020-01627-8. Epub 2020 Mar 31.
- 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.
Jochen Senges, MD principal investigator
Stiftung Institut für Herzinfarktforschung (IHF)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Stiftung Institut fuer Herzinfarktforschung at 4 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: clinical events with LAA occlusion (time frame: 1 year follow-up (optional 2,3,5 years)). 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 NCT02230748, which also lists 2 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 6 Sep 2018.