Clinical trial NCT02230748: Left-Atrium-Appendage Occluder Register - GErmany
Official title: Left-Atrium-Appendage Occluder Register - GErmany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Keywords: LAA
LAA-Occluder
Atrial Fibrillation
AF
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 643
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with an performed or planned LAA -Occluder

Brief 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 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?

Eligibility criteria: Inclusion Criteria:

Intention to laa occluder

Exclusion Criteria:

Missing informed consent

Primary outcomes:
measure: Safety: clinical events with LAA occlusion
timeFrame: 1 year follow-up (optional 2,3,5 years)
Secondary outcomes:
measure: Effectiveness: LAA occlusion
timeFrame: 1 year follow-up (optional 2,3,5 years)
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Ludwigshafen
country: Germany
facility: Institut für Herzinfarkforschung Ludwigshafen
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim
city: München
country: Germany
facility: Isar Herzzentrum
Study officials:
affiliation: Stiftung Institut für Herzinfarktforschung (IHF)
name: Jochen Senges, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fastner 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.