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Austrian Left Atrial Appendage Closure Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03409159
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
Left atrial appendage (LAA) occlusion (LAAC) has been introduced to treat patients with indication of oral anticoagulation (OAC) for atrial fibrillation (AF) with contraindication to OAC. This registry aims to document all LAAC procedures in Austria.

Condition or disease Intervention/treatment
Atrial Fibrillation Left Atrial Appendage Closure Device: LAAC

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Austrian Left Atrial Appendage Closure Registry
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: LAAC
    Left atrial appendage closure


Primary Outcome Measures :
  1. Number of participants with successful left atrial appendage closure, as defined by European Society of Cardiology Guidelines [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Number of participants with death, stroke or bleeding [ Time Frame: 5 years ]
  2. Number of participants with procedure-related adverse events [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with atrial fibrillation, who received LAAC in Austria.
Criteria

Inclusion Criteria:

  • Patients who received LAAC in Austria

Exclusion Criteria:

  • Absence of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409159


Contacts
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Contact: Daniel Scherr, Assoc.Prof. PD Dr. +4331638512544 daniel.scherr@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Daniel Scherr, Assoc.Prof. PD Dr.         
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03409159    
Other Study ID Numbers: 29-355 ex 16/17
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes