Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure.
NCT ID: NCT05257954
Last Updated: 2023-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-03-01
2029-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old
Exclusion Criteria
* Severe neuropsychiatric impairment
18 Years
ALL
No
Sponsors
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Josep Rodes-Cabau
OTHER
Responsible Party
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Josep Rodes-Cabau
Principal Investigator
Locations
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IUCPQ_UL
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Melanie Cote
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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Frail-LAAC
Identifier Type: -
Identifier Source: org_study_id