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NCT03409159 Clinical Trial

Austrian Left Atrial Appendage Closure Registry

Atrial Fibrillation Clinical Trial

Official title:
Austrian Left Atrial Appendage Closure Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03409159
Other study ID # 29-355 ex 16/17
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 16, 2017
Est. completion date May 2024

Study information
Verified date September 2023
Source Medical University of Graz
Contact Daniel Scherr, Assoc.Prof. PD Dr.
Phone +4331638512544
Email daniel.scherr@medunigraz.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who received LAAC in Austria Exclusion Criteria: - Absence of informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LAAC
Left atrial appendage closure

Locations
Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with successful left atrial appendage closure, as defined by European Society of Cardiology Guidelines 30 days
Secondary Number of participants with death, stroke or bleeding 5 years
Secondary Number of participants with procedure-related adverse events 30 days
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