Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2025-12-16 @ 8:02 PM
Study NCT ID:
NCT06348394
Status:
None
Last Update Posted:
2025-06-06 00:00:00
First Post:
2024-03-12 00:00:00
Brief Title:
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion
Status:
None
Status Verified Date:
2025-06
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:
ICETEE
Brief Summary:
The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography (ICE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices.
Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks \>5 mm on color doppler.
Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.
Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks \>5 mm on color doppler.
Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.
Detailed Description:
The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography ICE to guide implantation of percutaneous left atrial appendage closure LAAC devices
Primary endpoints include procedural success following implantation of the left atrial appendage occlusion LAAO device Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks 5 mm on color doppler
Secondary end points include periprocedural complications such as pericardial effusiontamponade stroke death vascular complications and device embolization procedural characteristics total duration fluoroscopy time contrast volume Length of hospital stay cost of hospitalization in-hospital patient satisfaction and clinical alterations at 45-day follow-up
Primary endpoints include procedural success following implantation of the left atrial appendage occlusion LAAO device Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks 5 mm on color doppler
Secondary end points include periprocedural complications such as pericardial effusiontamponade stroke death vascular complications and device embolization procedural characteristics total duration fluoroscopy time contrast volume Length of hospital stay cost of hospitalization in-hospital patient satisfaction and clinical alterations at 45-day follow-up
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?:
False
Is an FDA AA801 Violation?:
None