NCT04800913 The Role of Multimodality Imaging in Left Atrial Appendage Closure
| NCT ID | NCT04800913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hungarian Institute of Cardiology |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2021-11-08 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2021-11-08 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 complications (PDL, device thrombi).
Eligibility Criteria
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
Contact & Investigator
Anita Zadori, MD, PhD
PRINCIPAL INVESTIGATOR
0036303837011, anita.zadori@gokvi.hu
Frequently Asked Questions
Who can join the NCT04800913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04800913 currently recruiting?
Yes, NCT04800913 is actively recruiting participants. Contact the research team at peter.andreka@gokvi.hu for enrollment information.
Where is the NCT04800913 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT04800913 clinical trial?
NCT04800913 is sponsored by Hungarian Institute of Cardiology. The principal investigator is Anita Zadori, MD, PhD at 0036303837011, anita.zadori@gokvi.hu. The trial plans to enroll 44 participants.
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