Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455644
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-04
Brief Title:
Accuracy of LAA Occluder Size Selection CT vs DSA During Combined AF Ablation and LAA Occlusion
Sponsor:
First Affiliated Hospital of Shantou University Medical College
Organization:
First Affiliated Hospital of Shantou University Medical College
Study Overview
Official Title:
The Accuracy of Left Atrial Appendage Occluder Size Selection Between Preoperative CT and Intraoperative DSA Evaluation During a Combined Atrial Fibrillation Ablation and Left Atrial Appendage Occlusion Procedure
Status:
RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
This study is a prospective multi-center randomized controlled trial The subjects are patients scheduled to undergo a combined procedure of atrial fibrillation AF ablation and left atrial appendage LAA occlusion After signing the informed consent form the subjects will be randomly assigned to either the cardiac Computed Tomography CT group or the Digital Subtraction Angiography DSA group The operator will select the appropriate LAA occluder size for implantation based on different measurement methods All subjects will undergo clinical follow-up before discharge and at 3 months postoperatively as well as telephone follow-up 1-5 years after the surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None