Left-Atrium-Appendage Occluder Register - GErmany

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02230748

Acronym

LAARGE

Enrollment

643

Registered

2014-09-03

Start date

2014-07-31

Completion date

2017-03-27

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Stroke

Keywords

LAA, LAA-Occluder, Atrial Fibrillation, AF

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?

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Intention to laa occluder

Exclusion criteria

Missing informed consent

Design outcomes

Primary

Measure	Time frame	Description
Safety: clinical events with LAA occlusion	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

Measure	Time frame	Description
Effectiveness: LAA occlusion	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.

Countries

Germany

Outcome results