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The Role of Multimodality Imaging in Left Atrial Appendage Closure

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hungary
Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center)
RECRUITING
Budapest
Contact Information
Primary
Peter Andreka, MD, PhD
peter.andreka@gokvi.hu
0036703820470
Backup
Geza Fontos, MD
geza.fontos@gokvi.hu
0036703820358
Time Frame
Start Date: 2021-11-08
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 44
Treatments
Experimental: Multimodal imaging
Preoperative 2D/3D TOE AND MDCT for appendage characterisation and sizing~Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success~Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus)
Experimental: Standard imaging
Preoperative MDCT for appendage characterisation and sizing~Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success~Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus)
Related Therapeutic Areas
Sponsors
Leads: Hungarian Institute of Cardiology

This content was sourced from clinicaltrials.gov

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