Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04800913
Status:
RECRUITING
Last Update Posted:
2023-04-19
First Post:
2021-03-04
Brief Title:
The Role of Multimodality Imaging in Left Atrial Appendage Closure
Sponsor:
Hungarian Institute of Cardiology
Organization:
Hungarian Institute of Cardiology
Study Overview
Official Title:
The Role of Multimodality Imaging in Left Atrial Appendage Closure
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MILAAC
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
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 MDCTTOE 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 2D3D TOE fluoroscopy-angiography and multimodal postprocedural imaging 2D3D 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
The aim of the present prospective randomized single-centre study is to examine the non-inferiority of unimodal MDCT vs multimodal MDCTTOE 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 2D3D TOE fluoroscopy-angiography and multimodal postprocedural imaging 2D3D 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None