Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJosep Rodes-Cabau
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Transcatheter LAAC with any approved device
Age ≥18 years old
Disqualifiers
Unable to provide informed consent
Severe neuropsychiatric impairment
Trial population
Patients ≥18 years old undergoing Transcatheter LAAC with any approved device
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Prevalence of frailty
Evaluated with Clinical Frailty Scale (CFS) 9-point scale (1-Very fit to 9-Terminally ill)
Time frame
Baseline (before transcatheter Left Atrial Appendage Closure)2
Prevalence of frailty
Evaluated with Essential Frailty Toolset (EFT) (Scored 0 (least frail) to 5 (most frail)
Time frame
Baseline (before transcatheter Left Atrial Appendage Closure)3
Rate of all-cause mortality
Time frame
1-year follow-up4
Rate of ischemic events
Stroke
Time frame
1-year follow-upSecondary outcomes
1
Rate of All-cause mortality
Time frame
2, 3, 4 and 5-year follow-up2
Rate of ischemic events
Ischemic stroke or peripheral embolism
Time frame
2, 3, 4 and 5-year follow-up3
Rate of all-cause mortality and ischemic events
Rate of death from any cause + ischemic stroke or peripheral embolism
Time frame
2-, 3-, 4- and 5-year follow-up4
Rate of Rehospitalisation
Rate of any readmission to a hospital
Time frame
1-, 2-, 3-, 4- and 5-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Josep Rodes-Cabau
Lead sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor institution
Source ClinicalTrials.gov