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NCT Number: NCT05257954

Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IUCPQ_UL

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Melanie Cote

CONTACT

[email protected]

4186568711 ext. 2646

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to provide informed consent
  • Severe neuropsychiatric impairment

Treatment and study plan

Primary outcomes

  1. Prevalence of frailty

    Time frame: Baseline (before transcatheter Left Atrial Appendage Closure)

    Evaluated with Clinical Frailty Scale (CFS) 9-point scale (1-Very fit to 9-Terminally ill)

  2. Prevalence of frailty

    Time frame: Baseline (before transcatheter Left Atrial Appendage Closure)

    Evaluated with Essential Frailty Toolset (EFT) (Scored 0 (least frail) to 5 (most frail)

  3. Rate of all-cause mortality

    Time frame: 1-year follow-up

  4. Rate of ischemic events

    Time frame: 1-year follow-up

    Stroke

  5. Rate of all-cause mortality and ischemic events

    Time frame: 1-year follow-up

    all-cause mortality and Stroke

Secondary outcomes

  1. Rate of All-cause mortality

    Time frame: 2, 3, 4 and 5-year follow-up

  2. Rate of ischemic events

    Time frame: 2, 3, 4 and 5-year follow-up

    Ischemic stroke or peripheral embolism

  3. Rate of all-cause mortality and ischemic events

    Time frame: 2-, 3-, 4- and 5-year follow-up

    Rate of death from any cause + ischemic stroke or peripheral embolism

  4. Rate of Rehospitalisation

    Time frame: 1-, 2-, 3-, 4- and 5-year follow-up

    Rate of any readmission to a hospital

  5. Number of participants discharged to a healthcare facility

    Time frame: 1-month follow-up

    Number of participants discharged to convalescence center, rehabilitation center, assisted-living center, or nursing home; excluding those previously living in a facility.

  6. Rate of bleeding

    Time frame: 1-, 2-, 3-, 4- and 5-year follow-up

    Minor, Major and Life-threatening Bleeding

  7. Changes in quality of life

    Time frame: Baseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-up

    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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Josep Rodes-Cabau, MD, PhD

CONTACT

[email protected]

418-656-8711

Melanie Cote, MSc

CONTACT

[email protected]

418-656-8711 ext. 2646

Sponsors and collaborators

Lead sponsor

Josep Rodes-Cabau

Other

Registry information

Official study title

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

Acronym: Frail-LAAC

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Feb 25, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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