NCT05257954

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
34mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Mar 2022Mar 2029

First Submitted

Initial submission to the registry

February 10, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

February 10, 2022

Last Update Submit

March 23, 2026

Conditions

Transcatheter Left Atrial Appendage ClosureFrailty

Outcome Measures

Primary Outcomes (5)

  • Prevalence of frailty

    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

    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

    1-year follow-up

  • Rate of ischemic events

    Stroke

    1-year follow-up

  • Rate of all-cause mortality and ischemic events

    all-cause mortality and Stroke

    1-year follow-up

Secondary Outcomes (7)

  • Rate of All-cause mortality

    2, 3, 4 and 5-year follow-up

  • Rate of ischemic events

    2, 3, 4 and 5-year follow-up

  • Rate of all-cause mortality and ischemic events

    2-, 3-, 4- and 5-year follow-up

  • Rate of Rehospitalisation

    1-, 2-, 3-, 4- and 5-year follow-up

  • Number of participants discharged to a healthcare facility

    1-month follow-up

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Unable to provide informed consent
  • Severe neuropsychiatric impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCPQ_UL

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (14)

  • 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.

    PMID: 29146668RESULT

  • Boersma 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.

    PMID: 26822918RESULT

  • Landmesser 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.

    PMID: 29806820RESULT

  • Reddy 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.

    PMID: 29103847RESULT

  • Holmes 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.

    PMID: 31806131RESULT

  • Mesnier 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.

    PMID: 34266312RESULT

  • Panikker 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.

    PMID: 26935273RESULT

  • Hoogendijk 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.

    PMID: 31609228RESULT

  • Dent 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.

    PMID: 27039014RESULT

  • Kim 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.

    PMID: 27548070RESULT

  • Rodriguez-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.

    PMID: 22511289RESULT

  • Church 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.

    PMID: 33028215RESULT

  • Hinterbuchner 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.

    PMID: 26216870RESULT

  • Rockwood 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.

    PMID: 16129869RESULT

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Josep Rodes-Cabau, MD, PhD

CONTACT

418-656-8711josep.rodes@criucpq.ulaval.ca

Melanie Cote, MSc

CONTACT

418-656-8711melanie.cote@criucpq.ulaval.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2022

First Posted

February 25, 2022

Study Start

March 1, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2029

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)