NCT02230748

Left-Atrium-Appendage Occluder Register - GErmany

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 643 (actual)
• Sponsor: Stiftung Institut fuer Herzinfarktforschung · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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?

Conditions

• Atrial Fibrillation
• Stroke

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-01-01
• Completion: 2017-03-27
• First posted: 2014-09-03
• Last updated: 2018-09-06

Locations

4 sites across 1 country: Germany