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Completed

NCT Number: NCT02230748

Left-Atrium-Appendage Occluder Register - GErmany

* 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?

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Coburg, Coburg, Germany

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About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Intention to laa occluder

Exclusion criteria

Missing informed consent

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effectiveness: LAA occlusion

    Time frame: 1 year follow-up (optional 2,3,5 years)

    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.

Sponsors and collaborators

Lead sponsor

Stiftung Institut fuer Herzinfarktforschung

Other

Registry information

Acronym: LAARGE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 3, 2014
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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