REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion (RELEXAO)

May 11, 2024 updated by: Laurent Fauchier, University Hospital, Tours

REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion for Patients With Atrial Fibrillation in France

The objective of this observational non-randomized multicenter study is to compile real-world clinical characteristics and outcomes data for patients treated with LAA (left atrial appendage) closure systems in a daily clinical setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

400

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

All patients treated with percutaneous Left Atrial Appendage Occlusion among those referred to one of the French centers involved in this database

Description

Inclusion Criteria:

  • Patients who are eligible for a LAA occlusion device and treated with a commercially available device according to international and local guidelines and per physician discretion.

Exclusion Criteria:

  • None

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiovascular events
Time Frame: From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months
Death, Ischemic stroke, Transient ischemic attack, Major hemorrhage, Thrombus on device
From date of inclusion until the date of first documented event, whichever came first, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Laurent Fauchier, MD, PhD, Centre Hospitalier Universitaire de Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 8, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardio Tours RELEXAO

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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