Recruiting

Observational Study

Sponsor:

Josep Rodes-Cabau

Code:

NCT05257954

Conditions

Transcatheter Left Atrial Appendage Closure

Frailty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Transcatheter Left Atrial Appendage Closure

Frailty

Study ID

NCT05257954

Start date

Mar 1, 2022

Status verified date

Mar, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide informed consent
  • Severe neuropsychiatric impairment

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Prevalence of frailty [ Time Frame: Baseline (before transcatheter Left Atrial Appendage Closure) ]
  • Prevalence of frailty [ Time Frame: Baseline (before transcatheter Left Atrial Appendage Closure) ]
  • Rate of all-cause mortality [ Time Frame: 1-year follow-up ]
  • Rate of ischemic events [ Time Frame: 1-year follow-up ]
  • Rate of all-cause mortality and ischemic events [ Time Frame: 1-year follow-up ]

Central Contacts and Locations

Central contacts

Locations

IUCPQ_UL

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

More Information

Sponsor

Josep Rodes-Cabau

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Josep Rodes-Cabau on 2026-03-24.