CT group: After completing the AF ablation, select the appropriate LAA occluder based on preoperative CT measurements for implantation.
DSA group: After completing the AF ablation, select the appropriate LAA occluder based on intraoperative DSA measurements for implantation.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years;
2. Patients with non-valvular atrial fibrillation scheduled to undergo atrial fibrillation ablation and percutaneous left atrial appendage occlusion;
3. 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 Criteria:
1. Allergy to contrast agents or other conditions that preclude cardiac CT or DSA imaging;
2. Absence of clear images for measuring the diameter of the LAA in all layers of the CT scan;
3. Imaging indicates the presence of thrombus in the left atrium or LAA;
4. Patients with valvular AF (mechanical valve replacement or moderate to severe mitral stenosis combined with AF);
5. LAA depth \< 15 mm, or LAA anchor zone diameter \< 10 mm or \> 33 mm;
6. Female patients of childbearing age planning to become pregnant during the follow-up period required by this study;
7. 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;
8. Other conditions that the investigator deems make the participant unsuitable for this study.
Primary outcome measure(s)
Accuracy of LAA occluder size selection — 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.
Trial sites (5)
Facility
City
Region
Status
Foshan Nanhai District People's Hospital
Foshan
Guangdong
Not Yet Recruiting
The Second People's Hospital of Foshan
Foshan
Guangdong
Not Yet Recruiting
Meizhou Hospital of Traditional Chinese Medicine
Meizhou
Guangdong
Not Yet Recruiting
First Affiliated Hospital of Shantou University Medical College
Shantou
Guangdong
Recruiting
Guangdong Provincial Zhongshan Hospital of Traditional Chinese Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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