Frailty Clinical Trial
— Frail-LAACOfficial title:
Frailty in Patient Undergoing Percutaneous Left Atrial Appendage Closure The Frail-LAAC Study
NCT number | NCT05257954 |
Other study ID # | Frail-LAAC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | March 1, 2029 |
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | March 1, 2029 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Transcatheter LAAC with any approved device - Age =18 years old Exclusion Criteria: - Unable to provide informed consent - Severe neuropsychiatric impairment |
Country | Name | City | State |
---|---|---|---|
Canada | IUCPQ_UL | Quebec |
Lead Sponsor | Collaborator |
---|---|
Josep Rodes-Cabau |
Canada,
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. — View Citation
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 out — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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/M — View Citation
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 r — View Citation
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 Abs — View Citation
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-worl — View Citation
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 Co — View Citation
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. — View Citation
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, Gutie — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | Prevalence of frailty | Evaluated with Essential Frailty Toolset (EFT) (Scored 0 (least frail) to 5 (most frail) | Baseline (before transcatheter Left Atrial Appendage Closure) | |
Primary | Rate of all-cause mortality | 1-year follow-up | ||
Primary | Rate of ischemic events | Stroke | 1-year follow-up | |
Primary | Rate of all-cause mortality and ischemic events | all-cause mortality and Stroke | 1-year follow-up | |
Secondary | Rate of All-cause mortality | 2, 3, 4 and 5-year follow-up | ||
Secondary | Rate of ischemic events | Ischemic stroke or peripheral embolism | 2, 3, 4 and 5-year follow-up | |
Secondary | Rate of all-cause mortality and ischemic events | Rate of death from any cause + ischemic stroke or peripheral embolism | 2-, 3-, 4- and 5-year follow-up | |
Secondary | Rate of Rehospitalisation | Rate of any readmission to a hospital | 1-, 2-, 3-, 4- and 5-year follow-up | |
Secondary | 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. | 1-month follow-up | |
Secondary | Rate of bleeding | Minor, Major and Life-threatening Bleeding | 1-, 2-, 3-, 4- and 5-year follow-up | |
Secondary | 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.) | Baseline (before transcatheter Left Atrial Appendage Closure) and 1-year follow-up |
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