Transcatheter Left Atrial Appendage ClosureFrail-LAACNCT05257954
Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.
An observational study of Transcatheter Left Atrial Appendage Closure and Frailty, run by Josep Rodes-Cabau at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Left Atrial Appendage Closure, Frailty
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2022to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥18 years old undergoing Transcatheter LAAC with any approved device
Who may be able to join
- Transcatheter LAAC with any approved device
- Age ≥18 years old
Who cannot join
- Unable to provide informed consent
- Severe neuropsychiatric impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
IUCPQ_UL
Québec, Quebec, G1V 4G5
Melanie Cote, 4186568711 ext. 2646, melanie.cote@criucpq.ulaval.ca
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty
Evaluated with Clinical Frailty Scale (CFS) 9-point scale (1-Very fit to 9-Terminally ill)
Measured: Baseline (before transcatheter Left Atrial Appendage Closure)
Prevalence of frailty
Evaluated with Essential Frailty Toolset (EFT) (Scored 0 (least frail) to 5 (most frail)
Measured: Baseline (before transcatheter Left Atrial Appendage Closure)
Rate of all-cause mortality
Measured: 1-year follow-up
Rate of ischemic events
Stroke
Measured: 1-year follow-up
Rate of all-cause mortality and ischemic events
all-cause mortality and Stroke
Measured: 1-year follow-up
Secondary outcomes (7)
Rate of All-cause mortality
Measured: 2, 3, 4 and 5-year follow-up
Rate of ischemic events
Ischemic stroke or peripheral embolism
Measured: 2, 3, 4 and 5-year follow-up
Rate of all-cause mortality and ischemic events
Rate of death from any cause + ischemic stroke or peripheral embolism
Measured: 2-, 3-, 4- and 5-year follow-up
Rate of Rehospitalisation
Rate of any readmission to a hospital
Measured: 1-, 2-, 3-, 4- and 5-year follow-up
Number of participants discharged to a healthcare facility
Number of participants discharged to convalescence center, rehabilitation center, assisted-living center, or nursing home; excluding those previously living in a facility.
Measured: 1-month follow-up
Rate of bleeding
Minor, Major and Life-threatening Bleeding
Measured: 1-, 2-, 3-, 4- and 5-year follow-up
Changes in quality of life
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.)
Measured: Baseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Left Atrial Appendage ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josep Rodes-Cabau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josep Rodes-Cabau, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257954
- Sponsor's protocol ID
- Frail-LAAC
- Acronym
- Frail-LAAC
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asmarats L, Rodes-Cabau J. Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes. Circ Cardiovasc Interv. 2017 Nov;10(11):e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359.
PubMed 29146668Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.
PubMed 26822918Landmesser U, Tondo C, Camm J, Diener HC, Paul V, Schmidt B, Settergren M, Teiger E, Nielsen-Kudsk JE, Hildick-Smith D. Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry. EuroIntervention. 2018 Aug 3;14(5):e590-e597. doi: 10.4244/EIJ-D-18-00344.
PubMed 29806820Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
PubMed 29103847Holmes DR Jr, Reddy VY, Gordon NT, Delurgio D, Doshi SK, Desai AJ, Stone JE Jr, Kar S. Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. J Am Coll Cardiol. 2019 Dec 10;74(23):2878-2889. doi: 10.1016/j.jacc.2019.09.064.
PubMed 31806131Mesnier J, Cruz-Gonzalez I, Peral V, Nombela-Franco L, Freixa X, Laffond AE, Mas-Llado C, McInerney A, Regueiro A, O'Hara G, Rodes-Cabau J. Ten-Year Outcomes Following Percutaneous Left Atrial Appendage Closure in Patients With Atrial Fibrillation and Absolute or Relative Contraindications to Chronic Anticoagulation. Circ Cardiovasc Interv. 2021 Aug;14(8):e010821. doi: 10.1161/CIRCINTERVENTIONS.121.010821. Epub 2021 Jul 16. No abstract available.
PubMed 34266312Panikker S, Lord J, Jarman JW, Armstrong S, Jones DG, Haldar S, Butcher C, Khan H, Mantziari L, Nicol E, Hussain W, Clague JR, Foran JP, Markides V, Wong T. Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation. Eur Heart J. 2016 Dec 7;37(46):3470-3482. doi: 10.1093/eurheartj/ehw048. Epub 2016 Mar 1.
PubMed 26935273Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.
PubMed 31609228Dent E, Kowal P, Hoogendijk EO. Frailty measurement in research and clinical practice: A review. Eur J Intern Med. 2016 Jun;31:3-10. doi: 10.1016/j.ejim.2016.03.007. Epub 2016 Mar 31.
PubMed 27039014Kim DH, Kim CA, Placide S, Lipsitz LA, Marcantonio ER. Preoperative Frailty Assessment and Outcomes at 6 Months or Later in Older Adults Undergoing Cardiac Surgical Procedures: A Systematic Review. Ann Intern Med. 2016 Nov 1;165(9):650-660. doi: 10.7326/M16-0652. Epub 2016 Aug 23.
PubMed 27548070Rodriguez-Manas L, Feart C, Mann G, Vina J, Chatterji S, Chodzko-Zajko W, Gonzalez-Colaco Harmand M, Bergman H, Carcaillon L, Nicholson C, Scuteri A, Sinclair A, Pelaez M, Van der Cammen T, Beland F, Bickenbach J, Delamarche P, Ferrucci L, Fried LP, Gutierrez-Robledo LM, Rockwood K, Rodriguez Artalejo F, Serviddio G, Vega E; FOD-CC group (Appendix 1). Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):62-7. doi: 10.1093/gerona/gls119. Epub 2012 Apr 16.
PubMed 22511289Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.
PubMed 33028215Hinterbuchner L, Strohmer B, Hammerer M, Prinz E, Hoppe UC, Schernthaner C. Frailty scoring in transcatheter aortic valve replacement patients. Eur J Cardiovasc Nurs. 2016 Oct;15(6):384-97. doi: 10.1177/1474515115596640. Epub 2015 Jul 27.
PubMed 26216870Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure The Frail-LAAC Study
- ClinicalTrials.gov ID
- NCT05257954
- Acronym / sponsor ID
- Frail-LAAC / Frail-LAAC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Josep Rodes-CabauUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥18 years old undergoing Transcatheter LAAC with any approved device
Key inclusion criteria (2 listed)
- Transcatheter LAAC with any approved device
- Age ≥18 years old
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Severe neuropsychiatric impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Rate of all-cause mortality
Time frame: 1-year follow-up
Rate of ischemic events
Time frame: 1-year follow-up
Stroke
Rate of all-cause mortality and ischemic events
Time frame: 1-year follow-up
all-cause mortality and Stroke
7 secondary outcomes
Rate of All-cause mortality
Time frame: 2, 3, 4 and 5-year follow-up
Rate of ischemic events
Time frame: 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 Rehospitalisation
Time frame: 1-, 2-, 3-, 4- and 5-year follow-up
Number of participants discharged to a healthcare facility
Time frame: 1-month follow-up
Rate of bleeding
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 29146668Asmarats L, Rodes-Cabau J. Percutaneous Left Atrial Appendage Closure: Current Devices and Clinical Outcomes. Circ Cardiovasc Interv. 2017 Nov;10(11):e005359. doi: 10.1161/CIRCINTERVENTIONS.117.005359.
- Results publication: PubMed 26822918Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.
- Results publication: PubMed 29806820Landmesser U, Tondo C, Camm J, Diener HC, Paul V, Schmidt B, Settergren M, Teiger E, Nielsen-Kudsk JE, Hildick-Smith D. Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry. EuroIntervention. 2018 Aug 3;14(5):e590-e597. doi: 10.4244/EIJ-D-18-00344.
- Results publication: PubMed 29103847Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
- Results publication: PubMed 31806131Holmes DR Jr, Reddy VY, Gordon NT, Delurgio D, Doshi SK, Desai AJ, Stone JE Jr, Kar S. Long-Term Safety and Efficacy in Continued Access Left Atrial Appendage Closure Registries. J Am Coll Cardiol. 2019 Dec 10;74(23):2878-2889. doi: 10.1016/j.jacc.2019.09.064.
- Results publication: PubMed 34266312Mesnier J, Cruz-Gonzalez I, Peral V, Nombela-Franco L, Freixa X, Laffond AE, Mas-Llado C, McInerney A, Regueiro A, O'Hara G, Rodes-Cabau J. Ten-Year Outcomes Following Percutaneous Left Atrial Appendage Closure in Patients With Atrial Fibrillation and Absolute or Relative Contraindications to Chronic Anticoagulation. Circ Cardiovasc Interv. 2021 Aug;14(8):e010821. doi: 10.1161/CIRCINTERVENTIONS.121.010821. Epub 2021 Jul 16. No abstract available.
- Results publication: PubMed 26935273Panikker S, Lord J, Jarman JW, Armstrong S, Jones DG, Haldar S, Butcher C, Khan H, Mantziari L, Nicol E, Hussain W, Clague JR, Foran JP, Markides V, Wong T. Outcomes and costs of left atrial appendage closure from randomized controlled trial and real-world experience relative to oral anticoagulation. Eur Heart J. 2016 Dec 7;37(46):3470-3482. doi: 10.1093/eurheartj/ehw048. Epub 2016 Mar 1.
- Results publication: PubMed 31609228Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.
- Results publication: PubMed 27039014Dent E, Kowal P, Hoogendijk EO. Frailty measurement in research and clinical practice: A review. Eur J Intern Med. 2016 Jun;31:3-10. doi: 10.1016/j.ejim.2016.03.007. Epub 2016 Mar 31.
- Results publication: PubMed 27548070Kim DH, Kim CA, Placide S, Lipsitz LA, Marcantonio ER. Preoperative Frailty Assessment and Outcomes at 6 Months or Later in Older Adults Undergoing Cardiac Surgical Procedures: A Systematic Review. Ann Intern Med. 2016 Nov 1;165(9):650-660. doi: 10.7326/M16-0652. Epub 2016 Aug 23.
- Results publication: PubMed 22511289Rodriguez-Manas L, Feart C, Mann G, Vina J, Chatterji S, Chodzko-Zajko W, Gonzalez-Colaco Harmand M, Bergman H, Carcaillon L, Nicholson C, Scuteri A, Sinclair A, Pelaez M, Van der Cammen T, Beland F, Bickenbach J, Delamarche P, Ferrucci L, Fried LP, Gutierrez-Robledo LM, Rockwood K, Rodriguez Artalejo F, Serviddio G, Vega E; FOD-CC group (Appendix 1). Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):62-7. doi: 10.1093/gerona/gls119. Epub 2012 Apr 16.
- Results publication: PubMed 33028215Church S, Rogers E, Rockwood K, Theou O. A scoping review of the Clinical Frailty Scale. BMC Geriatr. 2020 Oct 7;20(1):393. doi: 10.1186/s12877-020-01801-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Left Atrial Appendage Closure and Frailty, run by Josep Rodes-Cabau at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep Rodes-Cabau, MD, PhD (418-656-8711, josep.rodes@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of frailty (time frame: Baseline (before transcatheter Left Atrial Appendage Closure)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257954, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.