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Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05257954
Acronym
Frail-LAAC
Enrollment
500
Registered
2022-02-25
Start date
2022-03-01
Completion date
2029-03-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty, Transcatheter Left Atrial Appendage Closure

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.

Interventions

None listed

Sponsors

Josep Rodes-Cabau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Transcatheter LAAC with any approved device * Age ≥18 years old

Exclusion criteria

* Unable to provide informed consent * Severe neuropsychiatric impairment

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of frailtyBaseline (before transcatheter Left Atrial Appendage Closure)Evaluated with Clinical Frailty Scale (CFS) 9-point scale (1-Very fit to 9-Terminally ill)
Rate of all-cause mortality1-year follow-up
Rate of ischemic events1-year follow-upStroke
Rate of all-cause mortality and ischemic events1-year follow-upall-cause mortality and Stroke

Secondary

MeasureTime frameDescription
Rate of All-cause mortality2, 3, 4 and 5-year follow-up
Rate of ischemic events2, 3, 4 and 5-year follow-upIschemic stroke or peripheral embolism
Rate of all-cause mortality and ischemic events2-, 3-, 4- and 5-year follow-upRate of death from any cause + ischemic stroke or peripheral embolism
Rate of Rehospitalisation1-, 2-, 3-, 4- and 5-year follow-upRate of any readmission to a hospital
Number of participants discharged to a healthcare facility1-month follow-upNumber of participants discharged to convalescence center, rehabilitation center, assisted-living center, or nursing home; excluding those previously living in a facility.
Rate of bleeding1-, 2-, 3-, 4- and 5-year follow-upMinor, Major and Life-threatening Bleeding
Changes in quality of lifeBaseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-upEvaluated 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.)

Countries

Canada

Contacts

CONTACTJosep Rodes-Cabau, MD, PhD
josep.rodes@criucpq.ulaval.ca418-656-8711
CONTACTMelanie Cote, MSc
melanie.cote@criucpq.ulaval.ca418-656-8711

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026