Left-Atrium-Appendage Occluder Register - GErmany "LAARGE"

Active, not recruiting

Phase N/A Results N/A

Trial Description

- 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

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

all patients with an performed or planned LAA -Occluder

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety: clinical events with LAA occlusion 1 year follow-up (optional 2,3,5 years) Yes
Secondary Effectiveness: LAA occlusion 1 year follow-up (optional 2,3,5 years) No

Sponsors