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The Role of Multimodality Imaging in Left Atrial Appendage Closure

RecruitingNAAges 18 Years - anyAllHungarian Institute of Cardiology
NCT04800913 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging. According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging. Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025 * Age above 18 years * Informed consent * Legal capacity Exclusion Criteria: * Age under 18 years * Pregnancy * Incapacitation * Absence of consent * Esophageal stenosis or diverticulum * Active esophageal bleeding * CT-contrast agent allergy * Severe chronic kidney disease (GFR\<15 ml/min/1,73 m2) * Appendage thrombus (mobile/with significant embolic risk) * Life expectancy shorter than 12 months * Active infection * Significant mitral valve stenosis * Mechanical heart valve * Open heart surgery is indicated
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What it tests

  • Multimodal imaging
  • Standard imaging
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Where

1 site
Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)
Budapest, Hungary
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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