NCT03409159

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

8.6 years

First QC Date

November 24, 2017

Last Update Submit

November 19, 2024

Conditions

Atrial FibrillationLeft Atrial Appendage Closure

Outcome Measures

Primary Outcomes (1)

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

    30 days

Secondary Outcomes (2)

  • Number of participants with death, stroke or bleeding

    5 years

  • Number of participants with procedure-related adverse events

    30 days

Interventions

LAACDEVICE

Left atrial appendage closure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with atrial fibrillation, who received LAAC in Austria.

You may qualify if:

  • Patients who received LAAC in Austria

You may not qualify if:

  • Absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Scherr, Assoc.Prof. PD Dr.

CONTACT

+4331638512544daniel.scherr@medunigraz.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

January 24, 2018

Study Start

May 16, 2017

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)