NCT04628078

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Aug 2015Jun 2027

Study Start

First participant enrolled

August 12, 2015

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

7.8 years

First QC Date

November 5, 2020

Last Update Submit

February 21, 2023

Conditions

Atrial FibrillationCardiovascular DiseasesThromboembolism

Keywords

Left atrial appendage closureAmuletWatchmanWatchman flxAcpCardiac computed tomography angiographyTransesophageal echocardiographyPeridevice leakThromboembolic eventsAtrial fibrillation

Outcome Measures

Primary Outcomes (11)

  • 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)

    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

Secondary Outcomes (3)

  • Percentage of atrial surface of device covered

    45 days - 3 months - 13months

  • Maximal Hypoattentuated Thickening on atrial surface of device

    45 days - 3 months - 13months

  • Percentage of device length coverage

    45 days - 3 months - 13months

Interventions

Use of echocardiography guidance for LAACOTHER

Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (13)

  • 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.

    PMID: 24352519BACKGROUND

  • 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.

    PMID: 24449944BACKGROUND

  • 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: 27244534BACKGROUND

  • 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: 8572814BACKGROUND

  • 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: 26088300BACKGROUND

  • 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: 25399274BACKGROUND

  • 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: 24998121BACKGROUND

  • 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: 27388826BACKGROUND

  • 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.

    PMID: 19683639BACKGROUND

  • 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.

    PMID: 23026477BACKGROUND

  • 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.

    PMID: 21670242BACKGROUND

  • 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.

    PMID: 27540038BACKGROUND

  • 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.

    PMID: 38795087DERIVED

MeSH Terms

Conditions

Atrial FibrillationCardiovascular DiseasesThromboembolismCerebral Palsy, Ataxic, Autosomal Recessive

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular Diseases

Study Officials

  • Lorenz Räber, Prof.

    Insel Gruppe AG, Inselspital, Universitätsklinik für Kardiologie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenz Räber, Prof.

CONTACT

31 632 09 29lorenz.raeber@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 13, 2020

Study Start

August 12, 2015

Primary Completion

June 1, 2023

Study Completion (Estimated)

June 1, 2027

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

CH(1)