LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure

Обзор

The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.

Подробное описание

Percutaneous left atrial appendage closure (LAAC) has established itself in clinical practice as a safe and efficient therapeutic option for atrial fibrillation patients with a relative/absolute contraindication to oral anticoagulation. The purpose of this observational study is to prospectively collect procedural and follow-up data of all patients submitted to a clinically indicate LAAC in order to assess the impact of patient characteristics, procedural technique (imaging used to guide/plan procedure, device implanted, post-procedural drug regimens, etc.) on procedural safety and efficacy. The endpoints will be assessed by means of clinical follow-up at 1-3-5 years after LAAC and imaging exams (TEE at1-3 months, CCTA at 1-13months).

Вмешательства

• Другое Use of echocardiography guidance for LAAC
  Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: 7 days]
• Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism [Срок оценки: 1 to 5 Years]
• Secondary Efficacy Endpoint - Incidence of technical success [Срок оценки: 7 days to 13 months]
• Feasibility Endpoint - Total procedure time (min) [Срок оценки: During the LAAC Procedure (≃ 60 minutes )]
• Feasibility Endpoint - dose of contrast medium (ml) [Срок оценки: During the LAAC Procedure (≃ 60 minutes )]
• Feasibility Endpoint - dose of x-ray (cGy.cm2) [Срок оценки: During the LAAC Procedure (≃ 60 minutes )]
• Feasibility Endpoint - number of device implantation attempt during the procedure (number) [Срок оценки: During the LAAC Procedure (≃ 60 minutes )]
• Feasibility Endpoint - number of device change during the procedure (number) [Срок оценки: During the LAAC Procedure (≃ 60 minutes )]
• Net Clinical Benefit Endpoint [Срок оценки: 1 to 5 years]
• LAA patency [Срок оценки: 45 days to 13 months]

Вторичные конечные точки (3)

• Percentage of atrial surface of device covered [Срок оценки: 45 days - 3 months - 13months]
• Maximal Hypoattentuated Thickening on atrial surface of device [Срок оценки: 45 days - 3 months - 13months]
• Percentage of device length coverage [Срок оценки: 45 days - 3 months - 13months]

Критерии участия

Критерии включения

• Age> 18
• Written informed consent to participate in the study
• Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure
• Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC

Критерии исключения

• None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Bern University Hospital Inselspital — Bern

Публикации

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ PMID 24352519
• Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990 PMID 24449944
• Gloekler S, Meier B, Windecker S. Left atrial appendage closure for prevention of cardioembolic events. Swiss Med Wkly. 2016 May 31;146:w14298. doi: 10.4414/smw.2016.14298. eCollection 2016. PMID 27244534
• Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X. PMID 8572814
• Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025. PMID 26088300
• Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192. PMID 25399274
• Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. PMID 24998121
• Koskinas KC, Shakir S, Fankhauser M, Nietlispach F, Attinger-Toller A, Moschovitis A, Wenaweser P, Pilgrim T, Stortecky S, Praz F, Raber L, Windecker S, Meier B, Gloekler S. Predictors of Early (1-Week) Outcomes Following Left Atrial Appendage Closure With Amplatzer Devices. JACC Cardiovasc Interv. 2016 Jul 11;9(13):1374-83. doi: 10.1016/j.jcin.2016.04.019. PMID 27388826

Идентификаторы

NCT: NCT04628078 · 2016-01742

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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