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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279406
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Laurent Fauchier, University Hospital, Tours

Brief Summary:
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Percutaneous Left Atrial Appendage Occlusion

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Study Type : Observational [Patient Registry]
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion for Patients With Atrial Fibrillation in France
Actual Study Start Date : February 1, 2012
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Percutaneous Left Atrial Appendage Occlusion
    Percutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279406


Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Laurent Fauchier, MD, PhD Centre Hospitalier Universitaire de Tours

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laurent Fauchier, Professor of Cardiology, University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03279406     History of Changes
Other Study ID Numbers: Cardio Tours RELEXAO
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Laurent Fauchier, University Hospital, Tours:
Atrial fibrillation
Stroke
Thrombus
Left atrial appendage
Bleeding
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes