- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03409159
Austrian Left Atrial Appendage Closure Registry
September 14, 2023 updated by: Medical University of Graz
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daniel Scherr, Assoc.Prof. PD Dr.
- Phone Number: +4331638512544
- Email: daniel.scherr@medunigraz.at
Study Locations
-
-
-
Graz, Austria, 8036
- Recruiting
- Medical University of Graz
-
Contact:
- Daniel Scherr, Assoc.Prof. PD Dr.
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with atrial fibrillation, who received LAAC in Austria.
Description
Inclusion Criteria:
- Patients who received LAAC in Austria
Exclusion Criteria:
- Absence of 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
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with successful left atrial appendage closure, as defined by European Society of Cardiology Guidelines
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with death, stroke or bleeding
Time Frame: 5 years
|
5 years
|
Number of participants with procedure-related adverse events
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 16, 2017
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
November 24, 2017
First Submitted That Met QC Criteria
January 17, 2018
First Posted (Actual)
January 24, 2018
Study Record Updates
Last Update Posted (Actual)
September 15, 2023
Last Update Submitted That Met QC Criteria
September 14, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29-355 ex 16/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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