Atrial Fibrillation and Other Dysrhythmias | Patient Clinical Trial
— FLAACOfficial title:
French Database of Left Atrial Appendage Closure
| NCT number | NCT02252861 |
| Other study ID # | FLAAC |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2013 |
| Est. completion date | September 2018 |
| Verified date | February 2021 |
| Source | Henri Mondor University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy. This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure. This database is strictly observational. Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
| Status | Completed |
| Enrollment | 840 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care - Signature of an inform consent form for inclusion of data recorded during care in the database Exclusion Criteria: none |
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor Hospital | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Henri Mondor University Hospital | French association for research in cardiology (ARCARD) |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France | 1 year | ||
| Secondary | Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures) | 1 year | ||
| Secondary | Death rate from cardiovascular disease after left atrial appendage closure | 1 year | ||
| Secondary | Unexplained Death rate after left atrial appendage closure | 1 year | ||
| Secondary | Adverse events related to the procedure | 1 year | ||
| Secondary | Cost of the procedure of left atrial appendage closure | Costs will be assessed for the duration of hospital stay, an expected average of 3 days | ||
| Secondary | Cost of patient follow-up after left atrial appendage closure | 1 year | ||
| Secondary | Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs) | 1 year |