Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.

Study Overview
=================
Brief Summary
-----------------
To assess the prevalence and severity of frailty in patients undergoing LAAC, as well as its association to peri-procedural and long-term outcomes and quality of life.

Detailed Description
-----------------
Transcatheter left atrial appendage closure (LAAC) has emerged as an alternative to anticoagulation for preventing thromboembolic events in patients with non-valvular atrial fibrillation and relative or absolute contraindications to oral anticoagulation (OAC). Procedural safety and success are now excellent with approximately 98% of successful procedures without major complications. LAAC seems to offer persisting protection against ischemic events in long-term reports, while also decreasing bleeding risk by reducing antithrombotic treatment intensity. However, patients undergoing LAAC in real-world practice are a high-risk population with a high rate of adverse events, mainly not related to the LAAC device-procedure. As a prophylactic intervention, the beneficial effects of LAAC increase over time, as more potential adverse events (ischemic and haemorrhagic) are prevented. Thus, it took approximately 5 years to reach cost-effectiveness (favoring LAAC versus oral anticoagulation) in the pooled data from PROTECT-AF and PREVAIL randomized controlled trials. Patients that experience early death after LAAC do not fully benefit from the costly procedure - that can be therefore considered futile. In a recent study, close to 1 on 5 LAAC recipient had either died or suffered from a major ischemic event within the first year after the procedure highlighting the need for better patient selection before LAAC. The definition of frailty is nonconsensual and has constantly evolved in the literature. Nonetheless, there is a general agreement that frailty is a multidimensional concept involving many domains (such as nutrition, mobility, strength and cognitive) and that frail patients are a high-risk population and vulnerable to stressors and adverse outcomes. Thus, considering this global definition, assessing frailty using multidomain scales is more appropriate to discriminate frail to non-frail patients. Frailty and its association to adverse events are well-known in transcatheter aortic valve replacement (TAVR). Despite being performed in a high-risk population, frailty has not yet been studied in LAAC although it could be a potent indicator for futile or harmful procedures. The implementation of frailty assessment into the routine practice could help identify vulnerable patients who will most likely less benefit from the LAAC procedure. Therefore, in this prospective multicenter trial, the investigators seek to explore frailty and its consequences in LAAC recipients.

Official Title
-----------------
Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure The Frail-LAAC Study

Conditions
-----------------
Transcatheter Left Atrial Appendage Closure, Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transcatheter LAAC with any approved device Age ≥18 years old Exclusion Criteria: Unable to provide informed consent Severe neuropsychiatric impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of frailty | Evaluated with Clinical Frailty Scale (CFS) 9-point scale (1-Very fit to 9-Terminally ill) | Baseline (before transcatheter Left Atrial Appendage Closure) | 
| Prevalence of frailty | Evaluated with Essential Frailty Toolset (EFT) (Scored 0 (least frail) to 5 (most frail) | Baseline (before transcatheter Left Atrial Appendage Closure) | 
| Rate of all-cause mortality |  | 1-year follow-up | 
| Rate of ischemic events | Stroke | 1-year follow-up | 
| Rate of all-cause mortality and ischemic events | all-cause mortality and Stroke | 1-year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of All-cause mortality |  | 2, 3, 4 and 5-year follow-up | 
| Rate of ischemic events | Ischemic stroke or peripheral embolism | 2, 3, 4 and 5-year follow-up | 
| Rate of all-cause mortality and ischemic events | Rate of death from any cause + ischemic stroke or peripheral embolism | 2-, 3-, 4- and 5-year follow-up | 
| Rate of Rehospitalisation | Rate of any readmission to a hospital | 1-, 2-, 3-, 4- and 5-year follow-up | 
| Number of participants discharged to a healthcare facility | Number of participants discharged to convalescence center, rehabilitation center, assisted-living center, or nursing home; excluding those previously living in a facility. | 1-month follow-up | 
| Rate of bleeding | Minor, Major and Life-threatening Bleeding | 1-, 2-, 3-, 4- and 5-year follow-up | 
| Changes in quality of life | Evaluated with EQ5-D questionnaire (5 dimensions questionnaire: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels : no problems, slight problems, moderate problems, severe problems and extreme problems.) | Baseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-up |