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RECRUITING
NCT04800913
NA

The Role of Multimodality Imaging in Left Atrial Appendage Closure

Sponsor: Hungarian Institute of Cardiology

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2021-11-08

Completion Date

2029-12-01

Last Updated

2024-10-22

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Multimodal imaging

Preoperative 2D/3D TOE and MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT

DIAGNOSTIC_TEST

Standard imaging

Preoperative MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT

Locations (1)

Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)

Budapest, Hungary