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The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of echocardiography guidance for LAAC | Other | Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Composite of Death, cerebrovascular events, cardiac tamponade, need for urgent surgery, need for cardiopulmonary resuscitation, device embolization, non vascular access-related major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) or acute kidney injury. | 7 days |
| Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism | Protection from cardiovascular death, ischemic stroke and systemic embolism | 1 to 5 Years |
| Secondary Efficacy Endpoint - Incidence of technical success | Technical success defined as adequate LAA ostium closure (without residual PDL>5mm or patent lobes) in absence of device complications (according to the Munich Consensus Document) | 7 days to 13 months |
| Feasibility Endpoint - Total procedure time (min) | Total procedure time (min) | During the LAAC Procedure (≃ 60 minutes ) |
| Feasibility Endpoint - dose of contrast medium (ml) | dose of contrast medium (ml) | During the LAAC Procedure (≃ 60 minutes ) |
| Feasibility Endpoint - dose of x-ray (cGy.cm2) | dose of x-ray (cGy.cm2) | During the LAAC Procedure (≃ 60 minutes ) |
| Feasibility Endpoint - number of device implantation attempt during the procedure (number) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of atrial surface of device covered | % (device sealing surrogate) | 45 days - 3 months - 13months |
| Maximal Hypoattentuated Thickening on atrial surface of device | mm (device sealing surrogate) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are scheduled to undergo to an elective Left Atrial Appendage Closure
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenz Räber, Prof. | Contact | 31 632 09 29 | +41 | lorenz.raeber@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Lorenz Räber, Prof. | Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bern University Hospital Inselspital | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24352519 | Background | 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, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):e28-e292. doi: 10.1161/01.cir.0000441139.02102.80. Epub 2013 Dec 18. No abstract available. | |
| 24449944 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
| C562856 | Cerebral Palsy, Ataxic, Autosomal Recessive |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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number of device implantation attempt during the procedure (number) |
| During the LAAC Procedure (≃ 60 minutes ) |
| Feasibility Endpoint - number of device change during the procedure (number) | number of device change during the procedure (number) | During the LAAC Procedure (≃ 60 minutes ) |
| Net Clinical Benefit Endpoint | Composite of death, stroke, systemic embolism, pulmonary embolism, myocardial infarction, and major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) not procedure-related. | 1 to 5 years |
| LAA patency | LAA patency and its subtypes as evaluated by TEE and/or CCTA | 45 days to 13 months |
| Device related thrombus | Device related thrombus detected by TEE and /or CCTA on the atrial surface of device | 45 days to 13months |
| 45 days - 3 months - 13months |
| Percentage of device length coverage | % (device sealing surrogate) | 45 days - 3 months - 13months |
| Background |
| 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 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4. |
| 27244534 | Background | 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. |
| 8572814 | Background | 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. |
| 26088300 | Background | 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. |
| 25399274 | Background | 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. |
| 24998121 | Background | 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. |
| 27388826 | Background | 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. |
| 19683639 | Background | Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, Mullin CM, Sick P; PROTECT AF Investigators. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009 Aug 15;374(9689):534-42. doi: 10.1016/S0140-6736(09)61343-X. |
| 23026477 | Background | Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012 Oct;33(19):2403-18. doi: 10.1093/eurheartj/ehs255. |
| 21670242 | Background | Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available. |
| 27540038 | Background | Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18. |
| 38795087 | Derived | Galea R, Bini T, Krsnik JP, Touray M, Temperli FG, Kassar M, Papadis A, Gloeckler S, Brugger N, Madhkour R, Seiffge DJ, Roten L, Siontis GCM, Heg D, Windecker S, Raber L. Pericardial Effusion After Left Atrial Appendage Closure: Timing, Predictors, and Clinical Impact. JACC Cardiovasc Interv. 2024 Jun 10;17(11):1295-1307. doi: 10.1016/j.jcin.2024.01.310. Epub 2024 May 22. |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |