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

March 23, 2026 updated by: Josep Rodes-Cabau

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients ≥18 years old undergoing Transcatheter LAAC with any approved device

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent
  • Severe neuropsychiatric impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline (before transcatheter Left Atrial Appendage Closure)
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)
Baseline (before transcatheter Left Atrial Appendage Closure)
Rate of all-cause mortality
Time Frame: 1-year follow-up
1-year follow-up
Rate of ischemic events
Time Frame: 1-year follow-up
Stroke
1-year follow-up
Rate of all-cause mortality and ischemic events
Time Frame: 1-year follow-up
all-cause mortality and Stroke
1-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of All-cause mortality
Time Frame: 2, 3, 4 and 5-year follow-up
2, 3, 4 and 5-year follow-up
Rate of ischemic events
Time Frame: 2, 3, 4 and 5-year follow-up
Ischemic stroke or peripheral embolism
2, 3, 4 and 5-year follow-up
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
2-, 3-, 4- and 5-year follow-up
Rate of Rehospitalisation
Time Frame: 1-, 2-, 3-, 4- and 5-year follow-up
Rate of any readmission to a hospital
1-, 2-, 3-, 4- and 5-year follow-up
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.
1-month follow-up
Rate of bleeding
Time Frame: 1-, 2-, 3-, 4- and 5-year follow-up
Minor, Major and Life-threatening Bleeding
1-, 2-, 3-, 4- and 5-year follow-up
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.)
Baseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Josep Rodes-Cabau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 10, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Frail-LAAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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