Overview

This trial is active, not recruiting.

Conditions atrial fibrillation, stroke
Sponsor Stiftung Institut fuer Herzinfarktforschung
Start date July 2014
End date January 2016
Trial size 643 participants
Trial identifier NCT02230748, LAARGE

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Safety: clinical events with LAA occlusion
time frame: 1 year follow-up (optional 2,3,5 years)

Secondary Outcomes

Measure
Effectiveness: LAA occlusion
time frame: 1 year follow-up (optional 2,3,5 years)

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Intention to laa occluder Exclusion Criteria: Missing informed consent

Additional Information

Official title Left-Atrium-Appendage Occluder Register - GErmany
Principal investigator Jochen Senges, MD
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?
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Stiftung Institut fuer Herzinfarktforschung.