NCT04800913

The Role of Multimodality Imaging in Left Atrial Appendage Closure

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Hungarian Institute of Cardiology · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Left atrial appendage closure (LAAC) is an increasingly used non-pharmacologic strategy to prevent stroke in patients with atrial fibrillation who have absolute or relative contraindications to long-term oral anticoagulant therapy, mainly due to previous major bleeding or high bleeding risk. As the majority of candidates are elderly patients with multiple morbidities, the reduction of procedural burden is of huge significance. The aim of the present prospective, randomized, single-centre study is to examine the non-inferiority of unimodal (MDCT) vs. multimodal (MDCT+TOE) preprocedural imaging in percutaneous left atrial appendage closure. The investigators are going to assess the success rate, safety and complications of LAAC procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural unimodal and multimodal appendage characterization and device sizing. Multimodal procedural guidance (2D/3D TOE, fluoroscopy-angiography) and multimodal postprocedural imaging (2D/3D TOE, MDCT) is going to be used to identify complications (peri-device leak, thrombus). The investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques. .

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-11-08
• Primary completion: 2028-12-31
• Completion: 2029-12-01
• First posted: 2021-03-16
• Last updated: 2024-10-22

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated device study