Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure. — Frail-LAAC  

Frailty Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Frailty

• NCT number: NCT05257954
• Study type: Observational
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: Josep Rodes-Cabau, MD, PhD
• Phone: 418-656-8711
• Email: josep.rodes@criucpq.ulaval.ca
• Status: Recruiting
• Start date: March 1, 2022
• Completion date: March 1, 2029