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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04628078
• Other study ID #: 2016-01742
• Status: Recruiting
• Start date: August 12, 2015
• Est. completion date: June 1, 2027

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: Lorenz Räber, Prof.
• Phone: 31 632 09 29
• Email: lorenz.raeber[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiovascular Diseases
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Switzerland	Bern University Hospital Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

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. — View Citation

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. Erratum In: Lancet. 2014 Jan 18;383(9913):218. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1186. — View Citation

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. Erratum In: Lancet. 2009 Nov 7;374(9701):1596. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: JAMA. 2015 Mar 10;313(10):1061. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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
Primary	Feasibility Endpoint - Total procedure time (min)	Total procedure time (min)	During the LAAC Procedure (? 60 minutes )
Primary	Feasibility Endpoint - dose of contrast medium (ml)	dose of contrast medium (ml)	During the LAAC Procedure (? 60 minutes )
Primary	Feasibility Endpoint - dose of x-ray (cGy.cm2)	dose of x-ray (cGy.cm2)	During the LAAC Procedure (? 60 minutes )
Primary	Feasibility Endpoint - number of device implantation attempt during the procedure (number)	number of device implantation attempt during the procedure (number)	During the LAAC Procedure (? 60 minutes )
Primary	Feasibility Endpoint - number of device change during the procedure (number)	number of device change during the procedure (number)	During the LAAC Procedure (? 60 minutes )
Primary	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
Primary	LAA patency	LAA patency and its subtypes as evaluated by TEE and/or CCTA	45 days to 13 months
Primary	Device related thrombus	Device related thrombus detected by TEE and /or CCTA on the atrial surface of device	45 days to 13months
Secondary	Percentage of atrial surface of device covered	% (device sealing surrogate)	45 days - 3 months - 13months
Secondary	Maximal Hypoattentuated Thickening on atrial surface of device	mm (device sealing surrogate)	45 days - 3 months - 13months
Secondary	Percentage of device length coverage	% (device sealing surrogate)	45 days - 3 months - 13months