Left-Atrium-Appendage Occluder Register - GErmany (LAARGE)

September 5, 2018 updated by: Stiftung Institut fuer Herzinfarktforschung
  • 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?

Study Overview

Status

Completed

Conditions

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?

Study Type

Observational

Enrollment (Actual)

643

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Coburg, Germany, 96450
        • Klinikum Coburg
      • Ludwigshafen, Germany, 67063
        • Institut für Herzinfarkforschung Ludwigshafen
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim
      • München, Germany, 80331
        • Isar Herzzentrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients with an performed or planned LAA -Occluder

Description

Inclusion Criteria:

Intention to laa occluder

Exclusion Criteria:

Missing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: clinical events with LAA occlusion
Time Frame: 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.
1 year follow-up (optional 2,3,5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness: LAA occlusion
Time Frame: 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.
1 year follow-up (optional 2,3,5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Investigators

  • Principal Investigator: Jochen Senges, MD, Stiftung Institut für Herzinfarktforschung (IHF)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 27, 2017

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAARGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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