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RecruitingNCT03409159Updated Nov 21, 2024

Austrian Left Atrial Appendage Closure Registry

An observational study in Atrial Fibrillation and Left Atrial Appendage Closure, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation
  • Left Atrial Appendage Closure

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with atrial fibrillation, who received LAAC in Austria.

Inclusion criteria

  • Patients who received LAAC in Austria

Exclusion criteria

Exclusion Criteria:

  • Absence of informed consent
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • DeviceLAAC

    Left atrial appendage closure

05

What researchers measure

Primary outcomes

  1. Number of participants with successful left atrial appendage closure, as defined by European Society of Cardiology Guidelines

    Time frame: 30 days

Secondary outcomes

  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

06

Study locations

1 of 1 sites recruiting
  • Medical University of Graz
    Graz, 8036, Austria
    • Daniel Scherr, Assoc.Prof. PD Dr. · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03409159
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
May 16, 2017
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 21, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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