Left-Atrium-Appendage Occluder Register - GErmany

Stroke Clinical Trial

— LAARGE  

Official title:

Left-Atrium-Appendage Occluder Register - GErmany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230748
• Other study ID #: LAARGE
• Status: Completed
• Start date: July 2014
• Est. completion date: March 27, 2017

Study information

• Verified date: September 2018
• Source: Stiftung Institut fuer Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 643
• Est. completion date: March 27, 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Intention to laa occluder

Exclusion Criteria:

Missing informed consent

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Locations

Country	Name	City	State
Germany	Klinikum Coburg	Coburg
Germany	Institut für Herzinfarkforschung Ludwigshafen	Ludwigshafen
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Isar Herzzentrum	München

Sponsors (1)

Lead Sponsor	Collaborator
Stiftung Institut fuer Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: clinical events with LAA occlusion	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.	1 year follow-up (optional 2,3,5 years)
Secondary	Effectiveness: LAA occlusion	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.	1 year follow-up (optional 2,3,5 years)