Evidence map›Paper›PMID 38741218›Full record

ArticleTrials2024

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients' stroke risk and preoperative atrial fibrillation status.

Christoffer L Madsen, Jesper Park-Hansen, Rakin Hadad, Anders M Greve, Helena Domínguez

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03724318 (Left Atrial Appendage Closure by Surgery-2), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03724318 naactive not recruitingnot on this map

Left Atrial Appendage Closure by Surgery-2

TypeinterventionalSponsorHelena DOMINGUEZRan2019 to 2026Enrolled1,500ConditionsStroke, Ischemic, Atrial FibrillationArmsclosure of the left atrium appendage
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Christoffer L MadsenDepartment of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, 2000, Frederiksberg, Copenhagen, Denmark. christoffer.laessoee.madsen@regionh.dk.ORCID http://orcid.org/0000-0003-0558-727X
Jesper Park-HansenDepartment of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, 2000, Frederiksberg, Copenhagen, Denmark.
Rakin HadadDepartment of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, 2000, Frederiksberg, Copenhagen, Denmark.
Anders M GreveDepartment of Clinical Biochemistry, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Helena DomínguezDepartment of Cardiology, Copenhagen University Hospital-Bispebjerg and Frederiksberg, Nordre Fasanvej 57, 2000, Frederiksberg, Copenhagen, Denmark.

Funding

Bispebjerg Hospital SD9804IMK Almene Fond 30206-093Novo Nordisk Fonden NNF18OC0052882
6 · The paper itself

Abstract

backgroundSurgical left atrial appendage (LAA) closure concomitant to open-heart surgery prevents thromboembolism in high-risk patients. Nevertheless, high-level evidence does not exist for LAA closure performed in patients with any CHA

methodsThe study is designed as a randomized, open-label, blinded outcome assessor, multicenter trial of adult patients undergoing first-time elective open-heart surgery. Patients with and without AF and any CHA DISCUSSION: The trial is expected to help form future guidelines within surgical LAA closure. This statistical analysis plan ensures transparency of analyses and limits potential reporting biases.

trial registrationClinicaltrials.gov, NCT03724318. Registered 26 October 2018, https://clinicaltrials.gov/study/NCT03724318 . PROTOCOL VERSION: https://doi.org/10.1016/j.ahj.2023.06.003 .

Indexed as

Atrial AppendageAtrial FibrillationCardiac Surgical ProceduresStrokeData Interpretation, StatisticalFemaleHumansIschemic Attack, TransientLeft Atrial Appendage ClosureMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicRisk AssessmentRisk FactorsTreatment OutcomeAtrial fibrillationLeft atrial appendage exclusionLeft atrial appendage occlusionOpen-heart surgeryStatistical analysis planStrokeTransient ischemic attack

Identifiers

PMID38741218
PMCPMC11092018

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.