REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion

Atrial Fibrillation Clinical Trial

— RELEXAO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279406
• Other study ID #: Cardio Tours RELEXAO
• Status: Completed
• Start date: February 1, 2012
• Est. completion date: September 1, 2018

Study information

• Verified date: May 2024
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	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