Comparing two ways to measure the heart's left atrial appendage before a device
Compares two imaging methods to pick a closure device size in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Accuracy of LAA Occluder Size Selection: CT vs. DSA During Combined AF Ablation and LAA Occlusion
Key facts
- Where
- Foshan, Meizhou, Shantou, and Zhongshan, ChinaSee the 5 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-valvular atrial fibrillation who are planned to have both an atrial fibrillation ablation and a left atrial appendage occlusion in one procedure.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-valvular atrial fibrillation, scheduled for atrial fibrillation ablation and percutaneous left atrial appendage occlusion
Main reasons for not taking part
- Allergy to contrast agents or other reasons that rule out cardiac CT or DSA imaging
- Blood clot in the left atrium or left atrial appendage on imaging
- Valvular atrial fibrillation (mechanical valve replacement, or moderate to severe mitral stenosis with atrial fibrillation)
- Left atrial appendage depth under 15 mm, or anchor zone diameter under 10 mm or over 33 mm
- Women of childbearing age planning to become pregnant during the follow-up period
Read by machine on 9 November 2026.
Where in China
- Foshan Nanhai District People's HospitalFoshan, ChinaNot yet recruiting
- The Second People's Hospital of FoshanFoshan, ChinaNot yet recruiting
- Meizhou Hospital of Traditional Chinese MedicineMeizhou, ChinaNot yet recruiting
- First Affiliated Hospital of Shantou University Medical College.Shantou, ChinaTaking people
- Guangdong Provincial Zhongshan Hospital of Traditional Chinese MedicineZhongshan, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- First Affiliated Hospital of Shantou University Medical College
- Trial code
- NCT06455644
- Record updated
- 12 June 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age ≥ 18 years; Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion; Able to understand the purpose of the trial, willing to participate in the study, and the subject or their legal representative has signed the informed consent form, and is willing to complete the follow-up according to the protocol requirements.
Exclusion: Currently participating in another clinical trial of drugs or medical devices and has not yet completed the primary endpoints of that study, which may confound the results of this study or affect the participant's compliance with the follow-up; Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging; Other conditions that the investigator deems make the participant unsuitable for this study; Female patients of childbearing age planning to become pregnant during the follow-up period required by this study; Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan; Imaging indicates the presence of thrombus in the left atrium or LAA; Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF); LAA depth < 15 mm, or LAA anchor zone diameter < 10 mm or > 33 mm.