MedTrace Logo

Post-approval Study of Percutaneous Left Atrial Appendage Closure ( FLAAC-2 )

NCT03434015 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1051

Last updated 2022-09-16

No results posted yet for this study

Summary

Patients with atrial fibrillation are at significant risk of thrombus formation in the left atrial appendage, which can lead to a stroke or systemic embolism. This risk justifies first-line prescribing of long-term oral anticoagulant therapy in these patients. Percutaneous left atrial appendage closure, is a new interventional cardiology technique for patients at high risk of stroke related to atrial fibrillation in whom long term anticoagulation therapy cannot be conducted. This procedure involves implantation of an occlusion device into the left atrial appendage to close it and prevent migration of thrombotic material that can cause distant embolism. Closure of the left atrial appendage avoids long term prescription of anticoagulants while protecting patients against the risk of systemic embolism and stroke. In 2016, two devices developed for transcutaneous closure of the left atrial appendage (WATCHMAN, Boston Scientific, AMPLATZER CARDIAC PLUG, S. Jude Medical and its evolution AMPLATZER AMULET) were included in the list of products reimbursable in France. The French national authorities have requested the realization of a register whose objectives will be to evaluate:

* The efficiency and safety of implanting devices in France
* The type and duration of antithrombotic treatment prescribed after left atrial appendage closure

Conditions

Sponsors & Collaborators

  • French Cardiology Society

    lead OTHER

Principal Investigators

  • Nicole NACCACHE · French Society of Cardio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2020-02-15
Completion
2021-10-07

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434015 on ClinicalTrials.gov