CT group
OtherAfter completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
NCT Number: NCT06455644
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Foshan Nanhai District People's Hospital, Foshan, Guangdong, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.
Time frame: During procedure
Accuracy is defined as: the occluder's anchor disc seats beyond the circumflex artery, the compression of the anchor disc after release is 3-6 mm, peri-device leak is ≤ 3 mm, and the occluder remains stable during the tug test.
Time frame: During procedure
Technical success of the LAA occlusion procedure without serious procedure-related complications
Time frame: 3 months
Proportion of peri-device leak at the occluder evaluated by TEE or CT
Time frame: During procedure
Total procedure time, AF ablation time, and LAA occlusion time
Time frame: 3 months
MAE is defined as unexplained death or any device or procedure-related complications, including but not limited to death, stroke, or transient ischemic attack (TIA), serious pericardial effusion/pericardial tamponade requiring pericardiocentesis or surgery, device embolization, life-threatening or severe bleeding events, and severe vascular access complications
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital of Shantou University Medical College
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05452356
Arrhythmias, Cardiac, Atrial Fibrillation
London, Ontario, Canada
View Trial DetailsNCT04922281
Arrhythmias, Cardiac, Atrial Fibrillation
Rochester, New York, United States
View Trial DetailsNCT06564012
Arrhythmias, Cardiac, Atrial Fibrillation
View Trial DetailsNCT05351775
Arrhythmias, Cardiac, Atrial Fibrillation
Turku, Finland
View Trial Details