Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Atrial Fibrillation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective randomized one-centre trialMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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 candidates of the procedure are mainly aged and multimorbid, the reduction of procedural burden is of huge significance for them. More comprehensive data about the optimal imaging of LAAC may contribute in finding the most accurate and least invasive way to plan and guide the procedure and to follow up the patients. The aim of the present prospective, randomized, single-centre study is to examine the potential advantages of preoperative multimodal imaging in percutaneous left atrial appendage closure. The investigators are going to assess the success rate, safety and long-term outcome of LAAC procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural multimodal (2D/3D transesophageal echocardiography /TOE/ and multidetector computed tomography /MDCT/) and standard (2D/3D TOE or MDCT) 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 reveal complications (peri-device leak, thrombus). The investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques, and ascertain the additive value of echocardiographic contrast agents in detecting postoperative complications. .

Tracking Information

NCT #
NCT04800913
Collaborators
Not Provided
Investigators
Principal Investigator: Anita Zadori, MD, PhD 0036303837011, zadori.anita@kardio.hu