NCT03279406

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

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

February 1, 2012

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

6.3 years

First QC Date

September 6, 2017

Last Update Submit

May 11, 2024

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationStrokeThrombusLeft atrial appendageBleeding

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Percutaneous Left Atrial Appendage OcclusionDEVICE

Percutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.

    PMID: 29622159DERIVED

MeSH Terms

Conditions

Atrial FibrillationStrokeThrombosisHemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and Thrombosis

Study Officials

  • Laurent Fauchier, MD, PhD

    Centre Hospitalier Universitaire de Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 12, 2017

Study Start

February 1, 2012

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

May 14, 2024

Record last verified: 2024-05