Left-Atrium-Appendage Occluder Register - GErmany

NCT02230748 | Completed

• 1 other identifier: LAARGE
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 4

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?

Conditions

Atrial Fibrillation; Stroke

Keywords

LAA; LAA-Occluder; Atrial Fibrillation; AF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness: LAA occlusion

  1 year follow-up (optional 2,3,5 years)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients with an performed or planned LAA -Occluder

You may qualify if:

• Intention to laa occluder

You may not qualify if:

• Missing informed consent

Sponsors & Collaborators

• Stiftung Institut fuer Herzinfarktforschung: lead

Study Sites (4)

Klinikum Coburg

Coburg, 96450, Germany

Location

Institut für Herzinfarkforschung Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitätsmedizin Mannheim

Mannheim, 68167, Germany

Location

Isar Herzzentrum

München, 80331, Germany

Location

Related Publications (2)

• Ansari U, Brachmann J, Lewalter T, Zeymer U, Sievert H, Ledwoch J, Geist V, Hochadel M, Schneider S, Senges J, Akin I, Fastner C. LAA occlusion is effective and safe in very high-risk atrial fibrillation patients with prior stroke: results from the multicentre German LAARGE registry. Clin Res Cardiol. 2024 Oct;113(10):1451-1462. doi: 10.1007/s00392-024-02376-8. Epub 2024 Jan 31.

  PMID: 38294498 DERIVED

• Fastner C, Brachmann J, Lewalter T, Zeymer U, Sievert H, Borggrefe M, Weiss C, Geist V, Krapivsky A, Kaunicke M, Mudra H, Hochadel M, Schneider S, Senges J, Akin I. Left atrial appendage closure in patients with a reduced left ventricular ejection fraction: results from the multicenter German LAARGE registry. Clin Res Cardiol. 2020 Nov;109(11):1333-1341. doi: 10.1007/s00392-020-01627-8. Epub 2020 Mar 31.

  PMID: 32236717 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Jochen Senges, MD

  Stiftung Institut für Herzinfarktforschung (IHF)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 27, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)