Left-Atrium-Appendage Occluder Register - GErmany

NCT ID: NCT02230748

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

643 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-03-27

Brief Summary

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* 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

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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

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Atrial Fibrillation Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Intention to laa occluder

Exclusion Criteria

Missing informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stiftung Institut fuer Herzinfarktforschung

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jochen Senges, MD

Role: PRINCIPAL_INVESTIGATOR

Stiftung Institut für Herzinfarktforschung (IHF)

Locations

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Klinikum Coburg

Coburg, , Germany

Site Status

Institut für Herzinfarkforschung Ludwigshafen

Ludwigshafen, , Germany

Site Status

Universitätsmedizin Mannheim

Mannheim, , Germany

Site Status

Isar Herzzentrum

München, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38294498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32236717 (View on PubMed)

Other Identifiers

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LAARGE

Identifier Type: -

Identifier Source: org_study_id

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